The following data is part of a premarket notification filed by Osypka Medical, Inc. with the FDA for Oscor Pace 101/101h And Accessories, St.jude Medical Model 3077 And Accessories,cardiotronic Pace 101 And Accessories.
| Device ID | K022939 |
| 510k Number | K022939 |
| Device Name: | OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | OSYPKA MEDICAL, INC. 7463 DRAPER AVE. La Jolla, CA 92037 |
| Contact | Markus J Osypka |
| Correspondent | Markus J Osypka OSYPKA MEDICAL, INC. 7463 DRAPER AVE. La Jolla, CA 92037 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-04 |
| Decision Date | 2002-10-03 |
| Summary: | summary |