510(k) K910253
K910253 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "LEEP REDIKIT". The FDA issued a decision of Substantially Equivalent on April 18, 1991. The device falls under product code HEE (Set, Anesthesia, Paracervical), a Class II device regulated under 21 CFR 884.5100. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1991
- Date Received
- January 22, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Anesthesia, Paracervical
- Device Class
- Class II
- Regulation Number
- 884.5100
- Review Panel
- OB
- Submission Type