The following data is part of a premarket notification filed by Jeff Klein Surgical, Inc. with the FDA for Klein Cork(tm).
| Device ID | K901715 |
| 510k Number | K901715 |
| Device Name: | KLEIN CORK(TM) |
| Classification | Adaptor, Catheter |
| Applicant | JEFF KLEIN SURGICAL, INC. P.O. BOX 1269 San Clemente, CA 92674 |
| Contact | Jacqueline Klein |
| Correspondent | Jacqueline Klein JEFF KLEIN SURGICAL, INC. P.O. BOX 1269 San Clemente, CA 92674 |
| Product Code | GCE |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-13 |
| Decision Date | 1990-05-11 |