The following data is part of a premarket notification filed by The Catheter Exchange, Inc. with the FDA for Deutsch Anti-blockage Wound Drain.
| Device ID | K052286 |
| 510k Number | K052286 |
| Device Name: | DEUTSCH ANTI-BLOCKAGE WOUND DRAIN |
| Classification | Catheter, Irrigation |
| Applicant | THE CATHETER EXCHANGE, INC. 16633 VENTURA BLVD. SUITE 735 Encino, CA 91436 |
| Contact | George P Teitelbaum |
| Correspondent | George P Teitelbaum THE CATHETER EXCHANGE, INC. 16633 VENTURA BLVD. SUITE 735 Encino, CA 91436 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-22 |
| Decision Date | 2005-10-21 |
| Summary: | summary |