The following data is part of a premarket notification filed by Handpiece Headquarters Inc. - Hpr Inc. with the FDA for Hhc, Score, Henry Schein Canister Handpiece.
| Device ID | K080682 |
| 510k Number | K080682 |
| Device Name: | HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | HANDPIECE HEADQUARTERS INC. - HPR INC. 2284 N. GLASSELL ST., UNIT A Orange, CA 92865 |
| Contact | Tina Steffanie-oak |
| Correspondent | Tina Steffanie-oak HANDPIECE HEADQUARTERS INC. - HPR INC. 2284 N. GLASSELL ST., UNIT A Orange, CA 92865 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-10 |
| Decision Date | 2008-09-11 |
| Summary: | summary |