FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELLMAN VAPOR-VAC II
K Number: K944558
·
Decision Apr 28, 1995
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
224
Basic Information
- Device Name
- ELLMAN VAPOR-VAC II
- K Number
- K944558
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- NORTH AMERICAN TECHNICAL SERVICES CORP.
- Date Received
- September 16, 1994
- Decision Date
- April 28, 1995
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by NORTH AMERICAN TECHNICAL SERVICES CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K974321 | HYDROTONE | Jun 22, 1998 | Substantially Equivalent |
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| K970592 | N/A | Jun 13, 1997 | Substantially Equivalent |
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| K944730 | MASSAGER | Feb 14, 1995 | Substantially Equivalent for Some Indications |
| K932204 | E-Z THERM 3 SECOND THERMOMETER | Oct 3, 1994 | Substantially Equivalent |
| K914364 | ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. | Sep 10, 1992 | Substantially Equivalent |