FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ML-800 AUTOELECTRONIC LIGHT SOURCE
K Number: K893828
·
Decision Jul 24, 1989
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
44
Applicant Total
11
Review Days
61
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Basic Information
- Device Name
- ML-800 AUTOELECTRONIC LIGHT SOURCE
- K Number
- K893828
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- M.P. Video, Inc.
- Date Received
- May 24, 1989
- Decision Date
- July 24, 1989
- Product Code
- FST
- 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 |
|---|---|---|---|
| FST | Light, Surgical, Fiberoptic | FDA class 2 | General, Plastic Surgery |
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Other Clearances by M.P. Video, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951386 | COMBINATION CAMERA/LIGHT SOURCE | Jun 30, 1995 | Substantially Equivalent |
| K943342 | MEDICAM XENON LIGHT SOURCE | Oct 17, 1994 | Substantially Equivalent |
| K942358 | AUTOCLAVEABLE MEDICAM 900 DIGICON CAMERA | Aug 8, 1994 | Substantially Equivalent |
| K941773 | MEDICAM 900 REMOTE | Jul 18, 1994 | Substantially Equivalent |
| K941693 | MEDICAM ENDOCOUPLER AND BEAMSPLITTER | Jun 27, 1994 | Substantially Equivalent |
| K882924 | MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS | Jul 26, 1988 | Substantially Equivalent |
| K871595 | SURGICAL CAMERA ACCESSORIES | May 7, 1987 | Substantially Equivalent |
| K871057 | MC-SERIES SURGICAL CAMERAS | Apr 3, 1987 | Substantially Equivalent |
| K871056 | MEDICAM S-4 SURGICAL CAMERA | Mar 31, 1987 | Substantially Equivalent |
| K820829 | MEDICAM | May 3, 1982 | Substantially Equivalent |