The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Micro-aire Soft-ice, Cold Therapy Compress.
| Device ID | K905207 |
| 510k Number | K905207 |
| Device Name: | MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS |
| Classification | Pack, Hot Or Cold, Reusable |
| Applicant | MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Contact | Moe Khosravi |
| Correspondent | Moe Khosravi MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Product Code | IME |
| CFR Regulation Number | 890.5700 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-01-22 |