510(k) K010277
- Device
- AMS FASCIAL-ANCHORING SYSTEM
- Applicant
- AMERICAN MEDICAL SYSTEMS, INC.
- 510(k) number
- K010277
- Product code
- NEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-03-26
- Date received
- 2001-01-30
- Regulation
- 878.4300
- Classification name
- Anchor, Fascial
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELSA LINKE
- Address
- 10700 Bren Rd. W. Minnetonka MN US 55343 55343
Source Documents#
Legacy Summary#
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FDA Review#
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