The following data is part of a premarket notification filed by Andover Medical, Inc. with the FDA for Modified Label Change To Model 5455 Surgical Cable.
| Device ID | K885171 |
| 510k Number | K885171 |
| Device Name: | MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01830 |
| Contact | Edward Shaughnessy |
| Correspondent | Edward Shaughnessy ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01830 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-13 |
| Decision Date | 1989-01-12 |