The following data is part of a premarket notification filed by Aci Medical, Inc. with the FDA for Unna-sleeve(tm).
| Device ID | K903532 |
| 510k Number | K903532 |
| Device Name: | UNNA-SLEEVE(TM) |
| Classification | Legging, Compression, Non-inflatable |
| Applicant | ACI MEDICAL, INC. 9249 GLENOAKS BL. Sun Valley, CA 91352 |
| Contact | Ed Arkans |
| Correspondent | Ed Arkans ACI MEDICAL, INC. 9249 GLENOAKS BL. Sun Valley, CA 91352 |
| Product Code | LLK |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-06 |
| Decision Date | 1990-11-02 |