FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECIMAN CUP & EMESIS BASIN
K Number: K792211
·
Decision Nov 16, 1979
Classifications
1
FEI Numbers
294
Registration Numbers
294
Same Product Code
22
Applicant Total
4
Review Days
14
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Basic Information
- Device Name
- SPECIMAN CUP & EMESIS BASIN
- K Number
- K792211
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- General Clinical Plastics Corp.
- Date Received
- November 2, 1979
- Decision Date
- November 16, 1979
- Product Code
- FMH
- Advisory Committee
- Pathology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMH | Container, Specimen, Sterile | FDA class 1 | Pathology |
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