FDA 510(k)
Substantially Equivalent
🇺🇸 United States
DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ
K Number: K853558
·
Decision Sep 5, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
10
Review Days
10
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Basic Information
- Device Name
- DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ
- K Number
- K853558
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- American White Cross, Inc.
- Date Received
- August 26, 1985
- Decision Date
- September 5, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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| K894802 | AWC BUTTERFLY WOUND CLOSURES | Jan 31, 1990 | Substantially Equivalent |
| K854809 | WHITE CROSS STERILE PAD 4IN. X 4IN. | Jan 13, 1986 | Substantially Equivalent |
| K853334 | NON-ADHERA ADHESIVE PAD 3X4 | Aug 21, 1985 | Substantially Equivalent |
| K852408 | EXTRA LARGE ADHESIVE STRIPS | Jul 29, 1985 | Substantially Equivalent |
| K852412 | NON-ADHERENT PAD | Jul 29, 1985 | Substantially Equivalent |
| K852462 | TRICOT ADHESIVE BANDAGE | Jul 26, 1985 | Substantially Equivalent |
| K850595 | 3 X 4 NON-ADHERENT PAD | Mar 11, 1985 | Substantially Equivalent |