STROVER HOOK

Instrument, Ligature Passing And Knot Tying

PLASTAFIL, INC.

The following data is part of a premarket notification filed by Plastafil, Inc. with the FDA for Strover Hook.

Pre-market Notification Details

Device IDK841617
510k NumberK841617
Device Name:STROVER HOOK
ClassificationInstrument, Ligature Passing And Knot Tying
Applicant PLASTAFIL, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeHCF  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-19
Decision Date1984-08-27

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