510(k) K911326
K911326 is an FDA 510(k) premarket notification submitted by Gesco Intl., Inc. for the device "OBSTETRICAL VACUUM CUP". The FDA issued a decision of Substantially Equivalent on August 14, 1991. The device falls under product code HDB (Extractor, Vacuum, Fetal), a Class II device regulated under 21 CFR 884.4340. Gesco Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 1991
- Date Received
- March 26, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extractor, Vacuum, Fetal
- Device Class
- Class II
- Regulation Number
- 884.4340
- Review Panel
- OB
- Submission Type