LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
FDA 510(k) clearance K971797 · decided 1997-07-22
Clearance details
- K-number
- K971797
- Device name
- LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
- Applicant
- Louisville Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-15
- Decision date
- 1997-07-22
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- HET
- Device class
- 2
- Regulation number
- 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.