FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
P.S.M. JUSTA COVER
K Number: K761072
·
Decision Dec 2, 1976
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
35
Applicant Total
14
Review Days
16
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Basic Information
- Device Name
- P.S.M. JUSTA COVER
- K Number
- K761072
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- The Owenby Co.
- Date Received
- November 16, 1976
- Decision Date
- December 2, 1976
- Product Code
- FXP
- 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 |
|---|---|---|---|
| FXP | Cover, Shoe, Operating-Room | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FXP), ordered by most recent decision date.
PRIMED SHOE COVERS, PRIMED HEAD COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FAR-EAST SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CONVERTORS IMPERVIOUS SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SHOE COVER, NON-STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIOMED SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by The Owenby Co.
| K Number | Device Name | ||
|---|---|---|---|
| K801628 | RESTRAINT, PROTECTIVE | Aug 7, 1980 | Substantially Equivalent |
| 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 |