The following data is part of a premarket notification filed by Bioseal with the FDA for Surgical Instrument Kit, Disposable.
| Device ID | K893814 |
| 510k Number | K893814 |
| Device Name: | SURGICAL INSTRUMENT KIT, DISPOSABLE |
| Classification | General Surgery Tray |
| Applicant | BIOSEAL 350 NORTH PALM Brea, CA 92621 |
| Contact | William L Runion |
| Correspondent | William L Runion BIOSEAL 350 NORTH PALM Brea, CA 92621 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-23 |
| Decision Date | 1989-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40612479125016 | K893814 | 000 |
| 40612479123920 | K893814 | 000 |
| 40612479123913 | K893814 | 000 |
| 40612479123906 | K893814 | 000 |
| 40612479123890 | K893814 | 000 |
| 40612479123883 | K893814 | 000 |
| 40612479123876 | K893814 | 000 |
| 40612479123869 | K893814 | 000 |
| 40612479123852 | K893814 | 000 |
| 40612479123845 | K893814 | 000 |
| 40612479123937 | K893814 | 000 |
| 40612479123944 | K893814 | 000 |
| 40612479125009 | K893814 | 000 |
| 40612479124996 | K893814 | 000 |
| 40612479124019 | K893814 | 000 |
| 40612479124002 | K893814 | 000 |
| 40612479123999 | K893814 | 000 |
| 40612479123982 | K893814 | 000 |
| 40612479123975 | K893814 | 000 |
| 40612479123968 | K893814 | 000 |
| 40612479123951 | K893814 | 000 |
| 40612479123838 | K893814 | 000 |