The following data is part of a premarket notification filed by Phoenix Steri-tech, Inc. with the FDA for Phoenix Steri-tech Sterile Dental Pack Gen-10001.
| Device ID | K920682 |
| 510k Number | K920682 |
| Device Name: | PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001 |
| Classification | Mask, Surgical |
| Applicant | PHOENIX STERI-TECH, INC. P.O. BOX 488 Suwanee, GA 30174 |
| Contact | Shepherd, Jr. |
| Correspondent | Shepherd, Jr. PHOENIX STERI-TECH, INC. P.O. BOX 488 Suwanee, GA 30174 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-14 |
| Decision Date | 1992-04-28 |