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.
Device ID | K863951 |
510k Number | K863951 |
Device Name: | P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE |
Classification | Handle, Scalpel |
Applicant | PRECISION SURGICAL INDUSTRIES, INC. 2507 RTE. 22 W Scotch Plains, NJ 07076 |
Contact | R. J Bedner |
Correspondent | R. J Bedner PRECISION SURGICAL INDUSTRIES, INC. 2507 RTE. 22 W Scotch Plains, NJ 07076 |
Product Code | GDZ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-10 |
Decision Date | 1986-10-24 |