The following data is part of a premarket notification filed by Pioneer Medical, Inc. with the FDA for Pioneer Pro-pump.
Device ID | K914220 |
510k Number | K914220 |
Device Name: | PIONEER PRO-PUMP |
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 | 1991-09-19 |
Decision Date | 1992-03-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00815965021683 | K914220 | 000 |
00815965021676 | K914220 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PIONEER PRO-PUMP 76207647 2809707 Live/Registered |
COOPERSURGICAL, INC. 2001-02-12 |