The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Medical Surgiflex(r) Suction-irrigation Prob.
Device ID | K932626 |
510k Number | K932626 |
Device Name: | CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
Contact | Todd J Polk |
Correspondent | Todd J Polk CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-01 |
Decision Date | 1994-06-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00821925000292 | K932626 | 000 |