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 |