The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Decherney Hysteroscopy Pump System.
Device ID | K873527 |
510k Number | K873527 |
Device Name: | DECHERNEY HYSTEROSCOPY PUMP SYSTEM |
Classification | Insufflator, Hysteroscopic |
Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
Contact | Jack Keller |
Correspondent | Jack Keller CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
Product Code | HIG |
CFR Regulation Number | 884.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-01 |
Decision Date | 1988-02-26 |