FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ISOLATION KIT
K Number: K770381
·
Decision Apr 5, 1977
Classifications
0
FEI Numbers
8
Registration Numbers
8
Same Product Code
80
Applicant Total
56
Review Days
36
Basic Information
- Device Name
- ISOLATION KIT
- K Number
- K770381
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN HOSPITAL SUPPLY CORP.
- Date Received
- February 28, 1977
- Decision Date
- April 5, 1977
- Product Code
- LDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDQ), ordered by most recent decision date.
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 |