FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MACLEAN-FOGG, TISSUE CASSETTES
K Number: K833857
·
Decision Dec 2, 1983
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
4
Applicant Total
23
Review Days
25
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Basic Information
- Device Name
- MACLEAN-FOGG, TISSUE CASSETTES
- K Number
- K833857
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Polymer Technology Corp.
- Date Received
- November 7, 1983
- Decision Date
- December 2, 1983
- Product Code
- IDZ
- 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 |
|---|---|---|---|
| IDZ | Cassettes, Tissue | 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 |
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