510(k) K013612
K013612 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "INCARE PELVIC FLOOR THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 19, 2002. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Hollister, Inc. has 84 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 19, 2002
- Date Received
- Nov 5, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Perineometer
- Device Class
- Class II
- Regulation Number
- 884.1425
- Review Panel
- GU
- Submission Type
- 510(k)