FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISOSHIELD(TM), SURGICAL EYE PROTECTOR
K Number: K894516
·
Decision Sep 12, 1989
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
606
Applicant Total
20
Review Days
55
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Basic Information
- Device Name
- VISOSHIELD(TM), SURGICAL EYE PROTECTOR
- K Number
- K894516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Polamedco, Inc.
- Date Received
- July 19, 1989
- Decision Date
- September 12, 1989
- Product Code
- FXX
- 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 |
|---|---|---|---|
| FXX | Mask, Surgical | FDA class 2 | General, Plastic Surgery |
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| K920900 | POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES | Mar 18, 1992 | Substantially Equivalent |
| K900456 | POLAMEDCO NASOPAHARYNGEAL AIRWAY | Apr 19, 1990 | Substantially Equivalent |
| K900457 | CUFFED LINDER NASOTRACHEAL AIRWAY | Apr 16, 1990 | Substantially Equivalent |
| K881496 | LINDER NASOTRACHEAL AIRWAY | May 31, 1988 | Substantially Equivalent |