510(k) K903002
K903002 is an FDA 510(k) premarket notification submitted by Gynopharma, Inc. for the device "PROBET (TM)". The FDA issued a decision of Substantially Equivalent on Apr 5, 1991. The device falls under product code HFF (Aspirator, Endometrial), a Class II device regulated under 21 CFR 884.1060. Gynopharma, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 5, 1991
- Date Received
- Jul 9, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Aspirator, Endometrial
- Device Class
- Class II
- Regulation Number
- 884.1060
- Review Panel
- OB
- Submission Type
- 510(k)