VARIOUS NON-STERILE CUSTOM TRAYS/KITS

Wound Dressing Kit

SURGIPRO CENTRAL, INC.

The following data is part of a premarket notification filed by Surgipro Central, Inc. with the FDA for Various Non-sterile Custom Trays/kits.

Pre-market Notification Details

Device IDK924690
510k NumberK924690
Device Name:VARIOUS NON-STERILE CUSTOM TRAYS/KITS
ClassificationWound Dressing Kit
Applicant SURGIPRO CENTRAL, INC. C/O PAT LAMB & ASSOCIATES P.O. BOX 431 Tarpon Springs,  FL  34689
ContactPatrick J Lamb
CorrespondentPatrick J Lamb
SURGIPRO CENTRAL, INC. C/O PAT LAMB & ASSOCIATES P.O. BOX 431 Tarpon Springs,  FL  34689
Product CodeMCY  
CFR Regulation Number880.5075 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-17
Decision Date1993-07-16

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