The following data is part of a premarket notification filed by William A. Cook Australia Pty Ltd with the FDA for Cook Vacuum Pump.
| Device ID | K160753 |
| 510k Number | K160753 |
| Device Name: | COOK Vacuum Pump |
| Classification | Accessory, Assisted Reproduction |
| Applicant | WILLIAM A. COOK AUSTRALIA PTY LTD 95 BRANDL STREET Eight Mile Plains, AU 4113 |
| Contact | Gordana Pozvek |
| Correspondent | Gordana Pozvek WILLIAM A. COOK AUSTRALIA PTY LTD 95 BRANDL STREET Eight Mile Plains Qld 4113, AU |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-18 |
| Decision Date | 2017-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002492752 | K160753 | 000 |
| 00827002516076 | K160753 | 000 |