FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE ORTHOPEDIC STOCKINETTE
K Number: K780547
·
Decision Apr 10, 1978
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
7
Applicant Total
8
Review Days
5
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STERILE ORTHOPEDIC STOCKINETTE
- K Number
- K780547
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Alba-Waldensian, Inc.
- Date Received
- April 5, 1978
- Decision Date
- April 10, 1978
- Product Code
- ILG
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ILG | Stocking, Elastic | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILG), ordered by most recent decision date.
ORTHOPEDIC STOCKINETTE
FDA 510(k)
FDA Class 1
·Physical Medicine
COMPRESSOGRIP ELASTIC STUMP SHRINKER#
FDA 510(k)
FDA Class 1
·Physical Medicine
STOCKINETTE, STERILE
FDA 510(k)
FDA Class 1
·Physical Medicine
ORTHOPEDIC STOCKINETTE
FDA 510(k)
FDA Class 1
·Physical Medicine
STOCKINETTE
FDA 510(k)
FDA Class 1
·Physical Medicine
ORTHOPEDIC TUBULAR STOCKINETTE
FDA 510(k)
FDA Class 1
·Physical Medicine
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 |
| K771913 | HEEL/ELBOW PROTECTOR | Nov 15, 1977 | Substantially Equivalent |