FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEAN AIR
K Number: K943201
·
Decision Feb 28, 1995
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
27
Review Days
238
Basic Information
- Device Name
- CLEAN AIR
- K Number
- K943201
- 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
- WALLACH SURGICAL DEVICES, INC.
- Date Received
- July 5, 1994
- Decision Date
- February 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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| K Number | Device Name | ||
|---|---|---|---|
| K021224 | ENDOCERVICAL BLOCK NEEDLE | Jul 12, 2002 | Substantially Equivalent |
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| K991669 | PMS 750 FINGERSWITCH | Aug 12, 1999 | Substantially Equivalent |
| K983840 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) | May 20, 1999 | Substantially Equivalent |
| K984306 | `THE INSEMINATOR' (PROPOSED) | Mar 1, 1999 | Substantially Equivalent |
| K983208 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR | Feb 22, 1999 | Substantially Equivalent |
| K963653 | WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM | Jun 11, 1997 | Substantially Equivalent |
| K963348 | WALLACH INTEGRATION UNIT | Mar 19, 1997 | Substantially Equivalent |