FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL COLDLIGHT, AX8
K Number: K770861
·
Decision Jun 17, 1977
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
28
Applicant Total
2
Review Days
39
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Basic Information
- Device Name
- SURGICAL COLDLIGHT, AX8
- K Number
- K770861
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Affiliated Hospital Products, Inc.
- Date Received
- May 9, 1977
- Decision Date
- June 17, 1977
- Product Code
- FTD
- 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 |
|---|---|---|---|
| FTD | Lamp, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTD), ordered by most recent decision date.
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
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VOLISTA 400; VOLISTA 600
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POLARIS 100/200
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ATRICURE DISSECTOR
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HM-LAMP II
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STRYKER KNIFELIGHT
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Other Clearances by Affiliated Hospital Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K771942 | TILT 10, CATALOG #S-2600 | Oct 27, 1977 | Substantially Equivalent |