The following data is part of a premarket notification filed by Three Dog Down with the FDA for Doctor Down --rescue Wrap.
| Device ID | K932539 |
| 510k Number | K932539 |
| Device Name: | DOCTOR DOWN --RESCUE WRAP |
| Classification | Bedding, Disposable, Medical |
| Applicant | THREE DOG DOWN 2500 PNC CENTER,201 E. 5TH ST. P.O. BOX 5715 Cincinnati, OH 45201 |
| Contact | Frederick Gibbell |
| Correspondent | Frederick Gibbell THREE DOG DOWN 2500 PNC CENTER,201 E. 5TH ST. P.O. BOX 5715 Cincinnati, OH 45201 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-26 |
| Decision Date | 1993-11-02 |