The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Wallace Trial Transfer Catheter, Model Tt 1816n.
| Device ID | K990348 |
| 510k Number | K990348 |
| Device Name: | WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N |
| Classification | Catheter, Assisted Reproduction |
| Applicant | COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484 |
| Contact | Debra A Pekar |
| Correspondent | Debra A Pekar COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-05 |
| Decision Date | 1999-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888937021166 | K990348 | 000 |
| 30888937021159 | K990348 | 000 |