FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EMC FLEXIBLE BIOPSY FORCEPS
K Number: K941816
·
Decision Jul 13, 1994
Classifications
1
FEI Numbers
188
Registration Numbers
188
Same Product Code
38
Applicant Total
3
Review Days
91
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Basic Information
- Device Name
- EMC FLEXIBLE BIOPSY FORCEPS
- K Number
- K941816
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Enterprise Medical Corp.
- Date Received
- April 13, 1994
- Decision Date
- July 13, 1994
- Product Code
- FCL
- 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 |
|---|---|---|---|
| FCL | Forceps, Biopsy, Non-Electric | FDA class 1 | Gastroenterology, Urology |
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