The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Medical Endometrial Suction Curette.
Device ID | K875084 |
510k Number | K875084 |
Device Name: | CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE |
Classification | Curette, Suction, Endometrial (and Accessories) |
Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
Contact | Todd Polk |
Correspondent | Todd Polk CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
Product Code | HHK |
CFR Regulation Number | 884.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-09 |
Decision Date | 1988-02-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00821925001145 | K875084 | 000 |
00821925005341 | K875084 | 000 |