INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER— 510(k) K974048
Substantially EquivalentHollister, Inc.
FDA 510(k) clearance K974048 for INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER, Substantially Equivalent on 1997-12-23. Applicant: Hollister, Inc.. Device class: 2.
Clearance details
- Applicant
- Hollister, Inc.
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Libertyville, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.