FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEEL/ELBOW PROTECTOR
K Number: K771913
·
Decision Nov 15, 1977
Classifications
1
FEI Numbers
374
Registration Numbers
374
Same Product Code
22
Applicant Total
8
Review Days
35
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Basic Information
- Device Name
- HEEL/ELBOW PROTECTOR
- K Number
- K771913
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6450
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Alba-Waldensian, Inc.
- Date Received
- October 11, 1977
- Decision Date
- November 15, 1977
- Product Code
- FMP
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FMP | Protector, Skin Pressure | FDA class 1 | General Hospital |
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Other Clearances by Alba-Waldensian, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020592 | ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 | Apr 3, 2002 | Substantially Equivalent |
| K961405 | ALBA HEALTH PAS WRAP SYSTEM | Dec 26, 1996 | Substantially Equivalent |
| K852091 | ALBA DRY BURN PAD | Jun 13, 1985 | Substantially Equivalent |
| K792357 | STERILE IMPERVIOUS ORTHOPEDIC STOCKIN | Dec 18, 1979 | Substantially Equivalent |
| K781964 | COMPRESSION DEVICES, LIMB | Dec 12, 1978 | Substantially Equivalent |
| K780570 | TUBULAR DRESSING RETAINER | Apr 19, 1978 | Substantially Equivalent |
| K780547 | STERILE ORTHOPEDIC STOCKINETTE | Apr 10, 1978 | Substantially Equivalent |