P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE

Handle, Scalpel

PRECISION SURGICAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Precision Surgical Industries, Inc. with the FDA for P.s.i.-disposable Scalpel Surgeons Handle.

Pre-market Notification Details

Device IDK863951
510k NumberK863951
Device Name:P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE
ClassificationHandle, Scalpel
Applicant PRECISION SURGICAL INDUSTRIES, INC. 2507 RTE. 22 W Scotch Plains,  NJ  07076
ContactR. J Bedner
CorrespondentR. J Bedner
PRECISION SURGICAL INDUSTRIES, INC. 2507 RTE. 22 W Scotch Plains,  NJ  07076
Product CodeGDZ  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-10
Decision Date1986-10-24

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