The following data is part of a premarket notification filed by Conphar, Inc. with the FDA for Conphar O.r. Head Cover-sterile.
| Device ID | K792106 |
| 510k Number | K792106 |
| Device Name: | CONPHAR O.R. HEAD COVER-STERILE |
| Classification | Appliance, Facial Fracture, External |
| Applicant | CONPHAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FYI |
| CFR Regulation Number | 878.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-25 |
| Decision Date | 1979-11-05 |