The following data is part of a premarket notification filed by Medtronic Andover Medical, Inc. with the FDA for Modified Model 5455 Disposable Surgical Cable.
Device ID | K882174 |
510k Number | K882174 |
Device Name: | MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
Applicant | MEDTRONIC ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01830 |
Contact | Edward Shaughnessy |
Correspondent | Edward Shaughnessy MEDTRONIC ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01830 |
Product Code | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-18 |
Decision Date | 1988-07-22 |