FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
P.S.M. BOTIQUE CAP
K Number: K761069
·
Decision Dec 30, 1976
Classifications
1
FEI Numbers
291
Registration Numbers
291
Same Product Code
31
Applicant Total
14
Review Days
44
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Basic Information
- Device Name
- P.S.M. BOTIQUE CAP
- K Number
- K761069
- 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 30, 1976
- Product Code
- FYF
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FYF | Cap, Surgical | FDA class 1 | General, Plastic Surgery |
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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 |
| K761068 | P.S.M. BOUFFANT CAP | Dec 30, 1976 | Substantially Equivalent |