HEWSON A.C.L. GUIDE SET

Retention Device, Suture

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Hewson A.c.l. Guide Set.

Pre-market Notification Details

Device IDK872608
510k NumberK872608
Device Name:HEWSON A.C.L. GUIDE SET
ClassificationRetention Device, Suture
Applicant CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
ContactPenny Rasmussen
CorrespondentPenny Rasmussen
CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater,  FL  33546
Product CodeKGS  
CFR Regulation Number878.4930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-06
Decision Date1987-09-16

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