FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RESTRAINT, PROTECTIVE
K Number: K801628
·
Decision Aug 7, 1980
Classifications
1
FEI Numbers
297
Registration Numbers
297
Same Product Code
26
Applicant Total
14
Review Days
23
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Basic Information
- Device Name
- RESTRAINT, PROTECTIVE
- K Number
- K801628
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- The Owenby Co.
- Date Received
- July 15, 1980
- Decision Date
- August 7, 1980
- Product Code
- IQK
- 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 |
|---|---|---|---|
| IQK | Orthosis, Cervical | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
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CERVICAL COLLARS & HEAD HALTERS
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Other Clearances by The Owenby Co.
| K Number | Device Name | ||
|---|---|---|---|
| K801627 | COVER, LIMB | Jul 28, 1980 | Substantially Equivalent |
| K801532 | STOCKINETTE, STERILE TWO PLY W/PULL TABS | Jul 28, 1980 | Substantially Equivalent |
| K801626 | ARM SLING | Jul 28, 1980 | Substantially Equivalent |
| K801531 | ARM SLING | Jul 21, 1980 | Substantially Equivalent |
| K790210 | STOCKINETTE, TUBULAR UNBLEACHED | Feb 27, 1979 | Substantially Equivalent |
| K780764 | NON-STERILE FOLDED GAUZE | Jun 6, 1978 | Substantially Equivalent |
| K780418 | BURN DRESSING PAD | Apr 10, 1978 | Substantially Equivalent |
| K770889 | BURN DRESSING KIT | Jul 11, 1977 | Substantially Equivalent |
| K761069 | P.S.M. BOTIQUE CAP | Dec 30, 1976 | Substantially Equivalent |
| K761068 | P.S.M. BOUFFANT CAP | Dec 30, 1976 | Substantially Equivalent |