FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MARCO SURGISCOPE OPERATION MICROSCOPES
K Number: K930439
·
Decision Jul 22, 1993
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
13
Applicant Total
15
Review Days
177
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Basic Information
- Device Name
- MARCO SURGISCOPE OPERATION MICROSCOPES
- K Number
- K930439
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4700
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Marco Ophthalmic, Inc.
- Date Received
- January 26, 1993
- Decision Date
- July 22, 1993
- Product Code
- HRM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Marco Ophthalmic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943234 | MS-30 AUTOMATIC PERIMETER | Jul 27, 1994 | Substantially Equivalent |
| K930437 | MARCO STANDARD RADIUSGAUGES | Aug 9, 1993 | Substantially Equivalent |
| K930444 | MARCO STANDARD KERATOMETERS | Aug 9, 1993 | Substantially Equivalent |
| K930442 | MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS | Aug 9, 1993 | Substantially Equivalent |
| K930438 | MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS | Aug 9, 1993 | Substantially Equivalent |
| K930443 | MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE | Jul 6, 1993 | Substantially Equivalent |
| K930449 | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR | Jul 6, 1993 | Substantially Equivalent |
| K930446 | MARCO TRIAL SETS | Jul 6, 1993 | Substantially Equivalent |
| K930441 | MARCO STANDARD LENSMETERS 101,201 | Jul 6, 1993 | Substantially Equivalent |
| K930440 | MARCO INTERNATIONAL STAND | Jul 6, 1993 | Substantially Equivalent |