The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Model Ms-2 Handpiece.
| Device ID | K982050 |
| 510k Number | K982050 |
| Device Name: | MODEL MS-2 HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Contact | Nelson Gendusa |
| Correspondent | Nelson Gendusa PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-11 |
| Decision Date | 1998-09-02 |
| Summary: | summary |