FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR
K Number: K931356
·
Decision Sep 7, 1993
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
3
Review Days
174
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Basic Information
- Device Name
- SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR
- K Number
- K931356
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sorenson Laboratories, Inc.
- Date Received
- March 17, 1993
- Decision Date
- September 7, 1993
- Product Code
- LQJ
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| LQJ | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | FDA class 2 | Ophthalmic |
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