FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROCEDURE & RECOVERY PATIENT SUIT
K Number: K803171
·
Decision Mar 4, 1981
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
5
Applicant Total
8
Review Days
79
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Basic Information
- Device Name
- PROCEDURE & RECOVERY PATIENT SUIT
- K Number
- K803171
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Alba Health Care
- Date Received
- December 15, 1980
- Decision Date
- March 4, 1981
- Product Code
- FYB
- 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 |
|---|---|---|---|
| FYB | Gown, Patient | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FYB), ordered by most recent decision date.
DISPOSABLE ISOLATION GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DISPOSABLE MEDICAL GOWNS
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FDA Class 2
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DENTAL BIB
FDA 510(k)
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·General, Plastic Surgery
SHIELD DISP. PATIENTS PONCHO GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PEDIATRICS GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Alba Health Care
| K Number | Device Name | ||
|---|---|---|---|
| K864689 | ALBA HEALTH CARE IODOFORM PACKING STRIP | Jan 20, 1987 | Substantially Equivalent |
| K861154 | ALBA HEALTH CARE PLAIN PACKING STRIP | Apr 15, 1986 | Substantially Equivalent |
| K851918 | INFANT PHOTOTHERAPY MASK | Jun 7, 1985 | Substantially Equivalent |
| K850881 | ALBA DRY BURN PAD | Apr 17, 1985 | Substantially Equivalent |
| K850904 | ALBA DRY BURN DRESSING | Apr 17, 1985 | Substantially Equivalent |
| K850241 | ALBA HEALTH CARE NON-ADHERING DRESSING | Mar 12, 1985 | Substantially Equivalent |
| K812904 | STERILE ORTHOPEDIC STOCKINETTE | Jan 18, 1982 | Substantially Equivalent |