The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Wallace Malleable Stylet-18cm, Model 1816st, Wallace Malleable Stylet-23cm, Model 1816nst.
| Device ID | K990349 |
| 510k Number | K990349 |
| Device Name: | WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST |
| Classification | Catheter, Assisted Reproduction |
| Applicant | COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484 |
| Contact | Debra A Parker |
| Correspondent | Debra A Parker 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 |
|---|---|---|
| 30888937021326 | K990349 | 000 |
| 30888937021319 | K990349 | 000 |
| 30888937021302 | K990349 | 000 |
| 30888937021296 | K990349 | 000 |
| 30888937021289 | K990349 | 000 |