FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE SURGICAL GARMENTS
K Number: K820363
·
Decision Mar 8, 1982
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
7
Review Days
27
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Basic Information
- Device Name
- DISPOSABLE SURGICAL GARMENTS
- K Number
- K820363
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Alphamedix, Inc.
- Date Received
- February 9, 1982
- Decision Date
- March 8, 1982
- Product Code
- FYA
- 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 |
|---|---|---|---|
| FYA | Gown, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Alphamedix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852706 | VERSABLADE | Nov 4, 1985 | Substantially Equivalent for Some Indications |
| K852633 | VERSABLADE | Nov 4, 1985 | Substantially Equivalent for Some Indications |
| K851272 | VERSAPHAGE | Jul 5, 1985 | Substantially Equivalent |
| K830812 | ALPHAMEDIX I/A HAND-PIECE, 500-001 | Jun 8, 1983 | Substantially Equivalent |
| K830703 | GLOMARK | Apr 28, 1983 | Substantially Equivalent |
| K820008 | VERSATOME I | Feb 22, 1982 | Substantially Equivalent |