The following data is part of a premarket notification filed by Delma Medical Instrument (guangzhou) Co., Ltd. with the FDA for Pacemaker High-speed Handpiece Model Pm-mq, Pm-m.
| Device ID | K101551 |
| 510k Number | K101551 |
| Device Name: | PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Contact | Leon Lu |
| Correspondent | Leon Lu DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-04 |
| Decision Date | 2010-09-09 |
| Summary: | summary |