FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RESTORE (A.K.A. CAPSURE)
K Number: K971359
·
Decision Nov 14, 1997
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
6
Applicant Total
3
Review Days
217
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Basic Information
- Device Name
- RESTORE (A.K.A. CAPSURE)
- K Number
- K971359
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5160
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nebl, Inc.
- Date Received
- April 11, 1997
- Decision Date
- November 14, 1997
- Product Code
- MNG
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNG | External Urethral Occluder, Urinary Incontinence-Control, Female | FDA class 1 | Gastroenterology, Urology |
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