FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MACLEAN-FOGG, DISP. BASE MOLD
K Number: K831900
·
Decision Jul 28, 1983
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
4
Applicant Total
23
Review Days
44
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Basic Information
- Device Name
- MACLEAN-FOGG, DISP. BASE MOLD
- K Number
- K831900
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Polymer Technology Corp.
- Date Received
- June 14, 1983
- Decision Date
- July 28, 1983
- Product Code
- KER
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KER | Container, Embedding | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KER), ordered by most recent decision date.
EMBEDDING RING
FDA 510(k)
FDA Class 1
·Pathology
EMBEDDING RINGS
FDA 510(k)
FDA Class 1
·Pathology
DISPOSABLE BASE MOLD
FDA 510(k)
FDA Class 1
·Pathology
LANCER BIOPSY HOLDER
FDA 510(k)
FDA Class 1
·Pathology
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| K951552 | BOSTON CONTACT LENS CASE | Jun 26, 1995 | Substantially Equivalent |
| K943177 | BOSTON(R) 7 - 30(ENFLUFOCON A) | Aug 25, 1994 | Substantially Equivalent |
| K942365 | BOSTON VII | Jun 23, 1994 | Substantially Equivalent |
| K923438 | BOSTON CONDITIONING SOLUTION | Dec 28, 1992 | Substantially Equivalent |
| K923587 | GLUCOSE TEST SYSTEM | Dec 28, 1992 | Substantially Equivalent |