FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇷 Greece
BRILLENERZEUGUNG POMBERGER OR MULTIPLE SPEC FRAMES
K Number: K931911
·
Decision Oct 1, 1993
Classifications
1
FEI Numbers
1086
Registration Numbers
1086
Same Product Code
197
Applicant Total
2
Review Days
168
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Basic Information
- Device Name
- BRILLENERZEUGUNG POMBERGER OR MULTIPLE SPEC FRAMES
- K Number
- K931911
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5842
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brillenerzeugung Pomberger
- Date Received
- April 16, 1993
- Decision Date
- October 1, 1993
- Product Code
- HQZ
- 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 |
|---|---|---|---|
| HQZ | Frame, Spectacle | FDA class 1 | Ophthalmic |
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Other Clearances by Brillenerzeugung Pomberger
| K Number | Device Name | ||
|---|---|---|---|
| K931910 | BRILLENERZEUGUNG POMBERGER OR MULTIPLE SUNGLASSES | Oct 1, 1993 | Substantially Equivalent |