The following data is part of a premarket notification filed by Howard Medical Co. with the FDA for A-sorb.
| Device ID | K882115 |
| 510k Number | K882115 |
| Device Name: | A-SORB |
| Classification | Gauze / Sponge,nonresorbable For External Use |
| Applicant | HOWARD MEDICAL CO. BOX 2 Chicago, IL 60690 |
| Contact | Ross Litton |
| Correspondent | Ross Litton HOWARD MEDICAL CO. BOX 2 Chicago, IL 60690 |
| Product Code | NAB |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-19 |
| Decision Date | 1988-10-03 |