FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIGA-LOOP SUTURE APPLICATOR
K Number: K993695
·
Decision Apr 13, 2000
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
29
Applicant Total
3
Review Days
163
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Basic Information
- Device Name
- LIGA-LOOP SUTURE APPLICATOR
- K Number
- K993695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4830
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hysterx, Inc.
- Date Received
- November 2, 1999
- Decision Date
- April 13, 2000
- Product Code
- GAL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAL | Suture, Absorbable, Natural | FDA class 2 | General, Plastic Surgery |
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