FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERIGAUZE WET DRESSING
K Number: K952420
·
Decision Jul 12, 1995
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
12
Review Days
50
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Basic Information
- Device Name
- STERIGAUZE WET DRESSING
- K Number
- K952420
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acacia Laboratories, Inc.
- Date Received
- May 23, 1995
- Decision Date
- July 12, 1995
- Product Code
- KMF
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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Other Clearances by Acacia Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952419 | STERIGAUZE GEL DRESSING | Jul 26, 1995 | Substantially Equivalent |
| K951861 | STERICARE WOUND CARE GEL | Jul 11, 1995 | Substantially Equivalent |
| K952414 | PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER | Jun 23, 1995 | Substantially Equivalent |
| K951914 | HYDRACARE ABSORBENT WOUND DRESSING | May 15, 1995 | Substantially Equivalent for Some Indications |
| K950344 | HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER | Mar 24, 1995 | Unknown |
| K913408 | STERILE PLASTIC DRAPE | Mar 12, 1992 | Substantially Equivalent |
| K901761 | STERILE SUCTION TUBING SET | May 7, 1990 | Substantially Equivalent |
| K892856 | NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS | Nov 8, 1989 | Substantially Equivalent |
| K892804 | NEWCHILL(TM) CARDIAC INSULATOR | Jul 14, 1989 | Substantially Equivalent |
| K884055 | SURGI-TAG(TM) STERILE LABEL SETS | Oct 13, 1988 | Substantially Equivalent |