The following data is part of a premarket notification filed by Precision Surgical Industries, Inc. with the FDA for P.s.i.-disposable Metal Handle Surgeons Scalpel.
| Device ID | K863950 |
| 510k Number | K863950 |
| Device Name: | P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL |
| Classification | Scalpel, One-piece |
| 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 | GDX |
| 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 |