FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
LUKENS BONE WAX (GAMMA RADIATION)
K Number: K791495
·
Decision Sep 24, 1979
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
11
Review Days
52
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Basic Information
- Device Name
- LUKENS BONE WAX (GAMMA RADIATION)
- K Number
- K791495
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Lukens Corp.
- Date Received
- August 3, 1979
- Decision Date
- September 24, 1979
- Product Code
- MTJ
- 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 |
|---|---|---|---|
| MTJ | Wax, Bone | FDA unclassified | Unknown |
Similar 510(k) Clearances
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Meril-Bonewax
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MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
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FDA Unclassified
·Unknown
Other Clearances by Lukens Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K880230 | SIXALYZER | Mar 16, 1988 | Substantially Equivalent |
| K800102 | STANFORD STERILE LAP SPONGES | Jan 28, 1980 | Substantially Equivalent |
| K792471 | STANFORD STERILE LAP SPONGES | Dec 20, 1979 | Substantially Equivalent |
| K770797 | TRAY, CATHETERIZATION W/FOLEY, STERILE | Jul 11, 1977 | Substantially Equivalent |
| K770795 | SHAVE PREP SET | Jul 11, 1977 | Substantially Equivalent |
| K770799 | TRAY, IRRIGATION, STERILE, BASIC | Jun 22, 1977 | Substantially Equivalent |
| K770796 | SKIN SCRUB PREP SET | Jun 22, 1977 | Substantially Equivalent |
| K770794 | SUTURE REMOVAL SET, STERILE | May 6, 1977 | Substantially Equivalent |
| K770798 | BLADES, SURGICAL, STERILE | May 6, 1977 | Substantially Equivalent |
| K770800 | HANDLES, BLADE, SURGICAL | May 6, 1977 | Substantially Equivalent |