FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFICATION OF SURGICAL EYESHIELD MASK
K Number: K934085
·
Decision Nov 12, 1993
Classifications
1
FEI Numbers
712
Registration Numbers
712
Same Product Code
54
Applicant Total
20
Review Days
84
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Basic Information
- Device Name
- MODIFICATION OF SURGICAL EYESHIELD MASK
- K Number
- K934085
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Threshold Industries, Inc.
- Date Received
- August 20, 1993
- Decision Date
- November 12, 1993
- Product Code
- HOY
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | FDA class 1 | Ophthalmic |
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Other Clearances by American Threshold Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971483 | SECURE-WRAP (TM) STERILIZATION WRAP | Jun 24, 1997 | Substantially Equivalent |
| K953879 | SURGEON'S CAP | Jan 5, 1996 | Substantially Equivalent |
| K953878 | BOUFFANT CAP | Jan 5, 1996 | Substantially Equivalent |
| K952114 | KOOL GARD SINGLES GOWN | Sep 25, 1995 | Substantially Equivalent |
| K952115 | BARRIER GOWN, KOOL-GARD BACKLESS GOWN | Sep 25, 1995 | Substantially Equivalent |
| K952116 | COVER GOWN | Sep 5, 1995 | Substantially Equivalent |
| K915530 | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE | Aug 17, 1992 | Substantially Equivalent |
| K915740 | DISPOSABLE O.R. TOWEL, STERILE | Jun 22, 1992 | Substantially Equivalent |
| K912110 | DISPOSABLE O.R. TOWEL | Jul 25, 1991 | Substantially Equivalent |
| K894383 | DISPOSABLE SHOE COVER | Sep 12, 1989 | Substantially Equivalent |