The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Videoscope.
Device ID | K861859 |
510k Number | K861859 |
Device Name: | CABOT VIDEOSCOPE |
Classification | Arthroscope |
Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
Contact | Angelucci, Iii |
Correspondent | Angelucci, Iii CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-14 |
Decision Date | 1986-05-30 |