The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Deflectable Electrophysiology Diagnostic Catheters.
| Device ID | K051220 |
| 510k Number | K051220 |
| Device Name: | REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Bruce R Lester |
| Correspondent | Bruce R Lester STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | NLH |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-12 |
| Decision Date | 2005-06-14 |
| Summary: | summary |