The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Fluid Barrier Boot Knee & Ankle-high.
| Device ID | K955835 |
| 510k Number | K955835 |
| Device Name: | FLUID BARRIER BOOT KNEE & ANKLE-HIGH |
| Classification | Cover, Shoe, Operating-room |
| Applicant | INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Contact | Brenda J Sparks |
| Correspondent | Brenda J Sparks INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Product Code | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1996-11-19 |
| Summary: | summary |