FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BURN DRESSING PAD
K Number: K780418
·
Decision Apr 10, 1978
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
16
Applicant Total
14
Review Days
27
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Basic Information
- Device Name
- BURN DRESSING PAD
- K Number
- K780418
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5180
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- The Owenby Co.
- Date Received
- March 14, 1978
- Decision Date
- April 10, 1978
- Product Code
- FPY
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FPY | Sheet, Burn | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPY), ordered by most recent decision date.
CP & S STERILE BURN SHEET
FDA 510(k)
FDA Class 1
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BURNSHIELD TRAUMA DRESSING
FDA 510(k)
FDA Class 1
·General Hospital
BURNSHIELD FIRE BLANKET
FDA 510(k)
FDA Class 1
·General Hospital
BURN SHEET
FDA 510(k)
FDA Class 1
·General Hospital
BURNS CASUALTY SHEET
FDA 510(k)
FDA Class 1
·General Hospital
BURNS CASUALTY SHEET LIMB WRAP
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 |
| 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 |
| 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 |