The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Face Mask.
| Device ID | K933683 |
| 510k Number | K933683 |
| Device Name: | PENTAX FACE MASK |
| Classification | Mask, Surgical |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Nanami V Nomiyama |
| Correspondent | Nanami V Nomiyama PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-29 |
| Decision Date | 1995-06-02 |