The following data is part of a premarket notification filed by Physician Industries, Inc. with the FDA for General Hygiene Kit.
| Device ID | K954068 |
| 510k Number | K954068 |
| Device Name: | GENERAL HYGIENE KIT |
| Classification | Absorber, Saliva, Paper |
| Applicant | PHYSICIAN INDUSTRIES, INC. 101 NORTH 700 WST P.O. BOX 540793 North Salt Lake, UT 84054 -0793 |
| Contact | Brian Baker |
| Correspondent | Brian Baker PHYSICIAN INDUSTRIES, INC. 101 NORTH 700 WST P.O. BOX 540793 North Salt Lake, UT 84054 -0793 |
| Product Code | KHR |
| CFR Regulation Number | 872.6050 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-30 |
| Decision Date | 1995-11-08 |