FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HANDLES, BLADE, SURGICAL
K Number: K770800
·
Decision May 6, 1977
Classifications
1
FEI Numbers
300
Registration Numbers
300
Same Product Code
47
Applicant Total
11
Review Days
4
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Basic Information
- Device Name
- HANDLES, BLADE, SURGICAL
- K Number
- K770800
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Lukens Corp.
- Date Received
- May 2, 1977
- Decision Date
- May 6, 1977
- Product Code
- GES
- 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 |
|---|---|---|---|
| GES | Blade, Scalpel | FDA class 1 | General, Plastic Surgery |
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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 |
| K791495 | LUKENS BONE WAX (GAMMA RADIATION) | Sep 24, 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 |