The following data is part of a premarket notification filed by Conmed Andover Medical, Inc. with the FDA for Disposable Surgical Cable.
Device ID | K941839 |
510k Number | K941839 |
Device Name: | DISPOSABLE SURGICAL CABLE |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
Applicant | CONMED ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01832 -1398 |
Contact | Dawn E Sissom |
Correspondent | Dawn E Sissom CONMED ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01832 -1398 |
Product Code | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-13 |
Decision Date | 1994-07-27 |