FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PINK CASSETTE CADDIE
K Number: K893728
·
Decision Sep 18, 1989
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
50
Applicant Total
2
Review Days
124
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Basic Information
- Device Name
- PINK CASSETTE CADDIE
- K Number
- K893728
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1850
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Technique Instruments, Inc.
- Date Received
- May 17, 1989
- Decision Date
- September 18, 1989
- Product Code
- IXA
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IXA | Cassette, Radiographic Film | FDA class 2 | Radiology |
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Other Clearances by Medical Technique Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902851 | MICROSCOPE DRAPE | Sep 10, 1990 | Substantially Equivalent |