The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Allegiance Kwik Heat Warm Perineal Pack.
| Device ID | K973770 |
| 510k Number | K973770 |
| Device Name: | ALLEGIANCE KWIK HEAT WARM PERINEAL PACK |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Contact | Patricia Sharpe-gregg |
| Correspondent | Patricia Sharpe-gregg ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-02 |
| Decision Date | 1997-11-13 |
| Summary: | summary |