The following data is part of a premarket notification filed by Surgeon Surgical Instrumentation, Inc. with the FDA for Hemorrhage Occludor.
| Device ID | K890447 |
| 510k Number | K890447 |
| Device Name: | HEMORRHAGE OCCLUDOR |
| Classification | Staple, Implantable |
| Applicant | SURGEON SURGICAL INSTRUMENTATION, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
| Contact | Don W Haar |
| Correspondent | Don W Haar SURGEON SURGICAL INSTRUMENTATION, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-27 |
| Decision Date | 1989-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868742000111 | K890447 | 000 |
| 00868742000104 | K890447 | 000 |