The following data is part of a premarket notification filed by Olson Medical Sales, Inc. with the FDA for Components For Cardiovascular Procedure Kit.
| Device ID | K992906 |
| 510k Number | K992906 |
| Device Name: | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | OLSON MEDICAL SALES, INC. 2101 COTTONTAIL LN. Somerset, NJ 08873 |
| Contact | Garry A Courtney |
| Correspondent | Garry A Courtney OLSON MEDICAL SALES, INC. 2101 COTTONTAIL LN. Somerset, NJ 08873 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-30 |
| Decision Date | 1999-11-10 |
| Summary: | summary |