Cleared Traditional

K803201 - LEMON GLYCERINE SWABS

K803201 · Walpak Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
-
Days
-
Risk

K803201 is an FDA 510(k) clearance for the LEMON GLYCERINE SWABS.

Submitted by Walpak Co. (Mchenry, US). The FDA issued a Cleared decision on December 17, 1980.

This device falls under the General Hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Walpak Co. devices

FDA 510(k) Submission Details - K803201

510(k) Number K803201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received December 17, 1980
Decision Date December 17, 1980
Days to Decision -
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -