The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Ultra Quiet Vacuum Pump & Regulator.
| Device ID | K992070 |
| 510k Number | K992070 |
| Device Name: | COOK ULTRA QUIET VACUUM PUMP & REGULATOR |
| Classification | Accessory, Assisted Reproduction |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Brenda Davis |
| Correspondent | Brenda Davis COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-18 |
| Decision Date | 1999-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002516076 | K992070 | 000 |
| 00827002492752 | K992070 | 000 |