The following data is part of a premarket notification filed by Advantage Credit Services, Inc. with the FDA for Edcool And Edcool Jr. Instant Cold Pack.
| Device ID | K871006 |
| 510k Number | K871006 |
| Device Name: | EDCOOL AND EDCOOL JR. INSTANT COLD PACK |
| Classification | Cushion, Wheelchair |
| Applicant | ADVANTAGE CREDIT SERVICES, INC. P.O. BOX 768 Kansas City, MO 64141 |
| Contact | Howard J Gerson |
| Correspondent | Howard J Gerson ADVANTAGE CREDIT SERVICES, INC. P.O. BOX 768 Kansas City, MO 64141 |
| Product Code | IMP |
| CFR Regulation Number | 890.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-13 |
| Decision Date | 1987-03-25 |