Cleared Traditional

K843114 - AMPCO PROCEDURE TRAYS / PACKS

K843114 · Associated Medical Products Co. · General Hospital
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Aug 1984
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K843114 is an FDA 510(k) clearance for the AMPCO PROCEDURE TRAYS / PACKS.

Submitted by Associated Medical Products Co. (Walker, US). The FDA issued a Cleared decision on August 8, 1984.

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 Associated Medical Products Co. devices

FDA 510(k) Submission Details - K843114

510(k) Number K843114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received August 08, 1984
Decision Date August 08, 1984
Days to Decision -
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -