The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Inflatable Air Splints.
| Device ID | K853600 |
| 510k Number | K853600 |
| Device Name: | INFLATABLE AIR SPLINTS |
| Classification | Splint, Extremity, Inflatable, External |
| Applicant | HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst, NY 11757 |
| Contact | William J Lacey |
| Correspondent | William J Lacey HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst, NY 11757 |
| Product Code | FZF |
| CFR Regulation Number | 878.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-27 |
| Decision Date | 1985-09-19 |