The following data is part of a premarket notification filed by Conco Medical Co. with the FDA for Shur-lock Ice Wrap System.
| Device ID | K904819 |
| 510k Number | K904819 |
| Device Name: | SHUR-LOCK ICE WRAP SYSTEM |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | CONCO MEDICAL CO. 380 HORACE ST. Bridgeport, CT 06610 |
| Contact | Ruth M Nemeth |
| Correspondent | Ruth M Nemeth CONCO MEDICAL CO. 380 HORACE ST. Bridgeport, CT 06610 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-24 |
| Decision Date | 1990-12-06 |