FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM
K Number: K871816
·
Decision Aug 3, 1987
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
17
Applicant Total
124
Review Days
84
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Basic Information
- Device Name
- STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM
- K Number
- K871816
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4620
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Stryker Corp.
- Date Received
- May 11, 1987
- Decision Date
- August 3, 1987
- Product Code
- EAY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EAY | Light, Fiber Optic, Dental | FDA class 1 | Dental |
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