The following data is part of a premarket notification filed by Pioneer Medical, Inc. with the FDA for Pioneer Pro-pump Dual Control.
| Device ID | K914241 |
| 510k Number | K914241 |
| Device Name: | PIONEER PRO-PUMP DUAL CONTROL |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | PIONEER MEDICAL, INC. IBE RESEARCG DRUVE-UNIT 6 Branford, CT 06405 |
| Contact | Michael D Cecchi |
| Correspondent | Michael D Cecchi PIONEER MEDICAL, INC. IBE RESEARCG DRUVE-UNIT 6 Branford, CT 06405 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-23 |
| Decision Date | 1992-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815965021669 | K914241 | 000 |
| 00815965021652 | K914241 | 000 |