The following data is part of a premarket notification filed by Hemostatic Surgery Corp. with the FDA for Shaw Ii Hemostatic Surgery System.
| Device ID | K902307 |
| 510k Number | K902307 |
| Device Name: | SHAW II HEMOSTATIC SURGERY SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HEMOSTATIC SURGERY CORP. FOUR EMBARCADERO CENTER, STE 3320 San Francisco, CA 94111 |
| Contact | Philip E Eggers |
| Correspondent | Philip E Eggers HEMOSTATIC SURGERY CORP. FOUR EMBARCADERO CENTER, STE 3320 San Francisco, CA 94111 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-22 |
| Decision Date | 1990-08-17 |