The following data is part of a premarket notification filed by Rapid Aid Ltd. with the FDA for Rapid Aid Instant Disposable Infant Heel Warmer.
| Device ID | K040856 |
| 510k Number | K040856 |
| Device Name: | RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER |
| Classification | Infant Heel Warmer (chemical Heat Pack) |
| Applicant | RAPID AID LTD. 4120 A SLADEVIEW CRESENT Mississauga, Ontario, CA L5l 5z3 |
| Contact | Anna Olasz |
| Correspondent | Anna Olasz RAPID AID LTD. 4120 A SLADEVIEW CRESENT Mississauga, Ontario, CA L5l 5z3 |
| Product Code | MPO |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-02 |
| Decision Date | 2004-05-03 |
| Summary: | summary |