The following data is part of a premarket notification filed by Performance Surgical Instruments Corp. with the FDA for Holmed Hand Held Instruments.
| Device ID | K913810 |
| 510k Number | K913810 |
| Device Name: | HOLMED HAND HELD INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PERFORMANCE SURGICAL INSTRUMENTS CORP. 600 SOUTH ST. Holbrook, MA 02343 |
| Contact | Russell Holmes |
| Correspondent | Russell Holmes PERFORMANCE SURGICAL INSTRUMENTS CORP. 600 SOUTH ST. Holbrook, MA 02343 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-26 |
| Decision Date | 1991-12-19 |