FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LARYNGOSTAT LARYNGOSCOPE HANDLE
K Number: K895954
·
Decision Oct 30, 1989
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
7
Review Days
19
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Basic Information
- Device Name
- LARYNGOSTAT LARYNGOSCOPE HANDLE
- K Number
- K895954
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Michigan Instruments, Inc.
- Date Received
- October 11, 1989
- Decision Date
- October 30, 1989
- Product Code
- CCW
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CCW | Laryngoscope, Rigid | FDA class 1 | Anesthesiology |
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