FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD)
K Number: K935723
·
Decision Apr 6, 1994
Classifications
1
FEI Numbers
877
Registration Numbers
878
Same Product Code
55
Applicant Total
3
Review Days
133
Basic Information
- Device Name
- SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD)
- K Number
- K935723
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CABOT SAFETY CORP.
- Date Received
- November 24, 1993
- Decision Date
- April 6, 1994
- Product Code
- LYU
- 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 |
|---|---|---|---|
| LYU | Accessory, Surgical Apparel | FDA class 1 | General, Plastic Surgery |
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