The following data is part of a premarket notification filed by Bird & Cronin, Inc. with the FDA for Comfor Foam Limb Holders- Single Strap.
| Device ID | K963462 |
| 510k Number | K963462 |
| Device Name: | COMFOR FOAM LIMB HOLDERS- SINGLE STRAP |
| Classification | Restraint, Protective |
| Applicant | BIRD & CRONIN, INC. 1200 TRAPP RD. Saint Paul, MN 55121 |
| Contact | Michael Frazer |
| Correspondent | Michael Frazer BIRD & CRONIN, INC. 1200 TRAPP RD. Saint Paul, MN 55121 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1996-11-21 |