The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Cook Aspiration Unit.
Device ID | K930900 |
510k Number | K930900 |
Device Name: | COOK ASPIRATION UNIT |
Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
Contact | Tammy Bacon |
Correspondent | Tammy Bacon COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
Product Code | JCX |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-22 |
Decision Date | 1993-07-22 |