FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BURN DRESSING KIT
K Number: K770889
·
Decision Jul 11, 1977
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
14
Review Days
56
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Basic Information
- Device Name
- BURN DRESSING KIT
- K Number
- K770889
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- The Owenby Co.
- Date Received
- May 16, 1977
- Decision Date
- July 11, 1977
- Product Code
- EFQ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
FDA 510(k)
FDA Unclassified
·Unknown
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
FDA 510(k)
FDA Unclassified
·Unknown
VITOP DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
FDA 510(k)
FDA Unclassified
·Unknown
CROSSTEX NON-WOVEN SPONGES
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE, SPONGES, CAT # 11-003
FDA 510(k)
FDA Unclassified
·Unknown
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 |
| K761069 | P.S.M. BOTIQUE CAP | Dec 30, 1976 | Substantially Equivalent |
| K761068 | P.S.M. BOUFFANT CAP | Dec 30, 1976 | Substantially Equivalent |