FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COTTON BALL KIT
K Number: K770588
·
Decision May 23, 1977
Classifications
1
FEI Numbers
402
Registration Numbers
403
Same Product Code
18
Applicant Total
56
Review Days
56
Basic Information
- Device Name
- COTTON BALL KIT
- K Number
- K770588
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5300
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN HOSPITAL SUPPLY CORP.
- Date Received
- March 28, 1977
- Decision Date
- May 23, 1977
- Product Code
- FRL
- 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 |
|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | FDA class 1 | General Hospital |
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Other Clearances by AMERICAN HOSPITAL SUPPLY CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K854739 | AMERICAN STERILE SURGICAL ABSORBENT TOWEL | Dec 27, 1985 | Substantially Equivalent |
| K854759 | AMERICAN STERILE MAYO STAND TRAY | Dec 17, 1985 | Substantially Equivalent |
| K832826 | AAP DOSIMETRY RELEASE OR BASIN SETS | Apr 23, 1984 | Substantially Equivalent |
| K830546 | DOSIMETRIC RELEASE | May 25, 1983 | Substantially Equivalent |
| K822990 | CONVERTORS PRIMARY WOUND DRESSING II | Apr 12, 1983 | Substantially Equivalent |
| K830343 | CONTAINER W/PRIMING SOLUTION | Mar 17, 1983 | Substantially Equivalent |
| K830301 | STRATUS FLUOROMETRIC ENZYME IMMUN0- | Feb 25, 1983 | Substantially Equivalent |
| K822755 | LATEX PENROSE TUBING | Jan 21, 1983 | Substantially Equivalent |
| K823418 | HEYER-SCHUTE UNIVERSAL URETERAL STENT | Dec 3, 1982 | Substantially Equivalent |
| K822966 | CONVERTORS DISPOSABLE DRESSING SPONGE | Nov 5, 1982 | Substantially Equivalent |