FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRAY, CATHETERIZATION W/FOLEY, STERILE
K Number: K770797
·
Decision Jul 11, 1977
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
11
Review Days
70
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Basic Information
- Device Name
- TRAY, CATHETERIZATION W/FOLEY, STERILE
- K Number
- K770797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Lukens Corp.
- Date Received
- May 2, 1977
- Decision Date
- July 11, 1977
- Product Code
- FRG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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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 |
| 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 |