FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STOCKINETTE, STERILE TWO PLY W/PULL TABS
K Number: K801532
·
Decision Jul 28, 1980
Classifications
1
FEI Numbers
681
Registration Numbers
681
Same Product Code
41
Applicant Total
14
Review Days
27
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Basic Information
- Device Name
- STOCKINETTE, STERILE TWO PLY W/PULL TABS
- K Number
- K801532
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- The Owenby Co.
- Date Received
- July 1, 1980
- Decision Date
- July 28, 1980
- Product Code
- FQM
- 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 |
|---|---|---|---|
| FQM | Bandage, Elastic | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FQM), ordered by most recent decision date.
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
FDA 510(k)
FDA Class 1
·General Hospital
BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE
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FDA Class 1
·General Hospital
COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE
FDA 510(k)
FDA Class 1
·General Hospital
SKIN SAVER SYSTEMS
FDA 510(k)
FDA Class 1
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ASPEN ESMARK BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
TUBE-BANDAGE FOR HUMAN DIGITS 200
FDA 510(k)
FDA Class 1
·General Hospital
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 |
| 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 |