The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Kwik Kold Peri Cold Pack (catalog Number Tbd).
| Device ID | K970399 |
| 510k Number | K970399 |
| Device Name: | KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1660 IOWA AVE., SUITE 100/200 Riverside, CA 92507 |
| Contact | Maryalice Smith |
| Correspondent | Maryalice Smith ALLEGIANCE HEALTHCARE CORP. 1660 IOWA AVE., SUITE 100/200 Riverside, CA 92507 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-04-03 |
| Summary: | summary |