Cleared Traditional

PROPHYLACTIC W/SPERMICIDAL LUBRICANT (K802354) - FDA 510(k) Clearance

K802354 · Schmid Laboratories, Inc. · Obstetrics & Gynecology device
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Sep 1980
Decision
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K802354 is an FDA 510(k) clearance for the PROPHYLACTIC W/SPERMICIDAL LUBRICANT.

Submitted by Schmid Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 25, 1980.

This device falls under the Obstetrics & Gynecology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K802354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received September 25, 1980
Decision Date September 25, 1980
Days to Decision -
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -