FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRINS CONTRAST BACKGROUND MATERIAL
K Number: K933310
·
Decision Aug 19, 1993
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
17
Applicant Total
6
Review Days
43
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Basic Information
- Device Name
- MICRINS CONTRAST BACKGROUND MATERIAL
- K Number
- K933310
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4700
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Micrins Surgical, Inc.
- Date Received
- July 7, 1993
- Decision Date
- August 19, 1993
- Product Code
- EPT
- 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 |
|---|---|---|---|
| EPT | Microscope, Surgical | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Micrins Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993970 | MICRINS MICROSURGICAL SUTURE | Mar 30, 2000 | Substantially Equivalent |
| K982278 | MICRINS MICRO ANASTOMOSIS CLAMP | Mar 26, 1999 | Substantially Equivalent |
| K872989 | MICRINS NEEDLE HOLDER | Aug 21, 1987 | Substantially Equivalent |
| K872990 | MICRINS SURGICAL SCISSOR | Aug 17, 1987 | Substantially Equivalent |
| K872991 | MICRINS FORCEPS 2010 | Aug 17, 1987 | Substantially Equivalent |