FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MASTEL LASER CLEAN ROOM, MODEL EBS-100
K Number: K043494
·
Decision Oct 4, 2005
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
74
Applicant Total
1
Review Days
291
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Basic Information
- Device Name
- MASTEL LASER CLEAN ROOM, MODEL EBS-100
- K Number
- K043494
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mastel Precision Surgical Instruments, Inc.
- Date Received
- December 17, 2004
- Decision Date
- October 4, 2005
- Product Code
- FYD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | FDA class 2 | General, Plastic Surgery |
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