FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GOWNS, SURGICAL
K Number: K844703
·
Decision Jan 10, 1985
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
14
Review Days
38
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Basic Information
- Device Name
- GOWNS, SURGICAL
- K Number
- K844703
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medicon, Inc.
- Date Received
- December 3, 1984
- Decision Date
- January 10, 1985
- 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 Medicon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962087 | SERVOTRONIC EC100 SYSTEM | Apr 23, 1997 | Substantially Equivalent |
| K952168 | TITANIUM MANDIBULAR FRACTURE SYSTEM | Jun 22, 1995 | Substantially Equivalent |
| K850855 | TENS GB1001 DEVICE | Jan 9, 1986 | Substantially Equivalent |
| K850852 | INFRARAX DEVICE | Aug 21, 1985 | Substantially Equivalent |
| K844702 | GAUZE ASORBABLE | Apr 1, 1985 | Substantially Equivalent |
| K844573 | ABSORBABLE GAUZE PRODUCTS | Mar 5, 1985 | Substantially Equivalent |
| K844574 | WHEELCHAIRS | Feb 21, 1985 | Substantially Equivalent |
| K844705 | SHOE COVERS | Jan 10, 1985 | Substantially Equivalent |
| K844704 | CAPS (O.R. NURSE, SURGICAL) | Jan 10, 1985 | Substantially Equivalent |
| K840034 | VACUUM STRETCHER IMMOBILIZER | Feb 27, 1984 | Substantially Equivalent |