FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
NON ADHERENT BANDAGE/SHEET
K Number: K833730
·
Decision Jan 27, 1984
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
33
Review Days
94
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Basic Information
- Device Name
- NON ADHERENT BANDAGE/SHEET
- K Number
- K833730
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- American Medical Disposable, Inc.
- Date Received
- October 25, 1983
- Decision Date
- January 27, 1984
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by American Medical Disposable, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K833734 | NEUROLOGICAL SPONGE ON PLASTIC STICK | Apr 23, 1984 | Substantially Equivalent |
| K833735 | AN ODOR ABSORBENT BANDAGE | Apr 23, 1984 | Substantially Equivalent |
| K833731 | BREATHABLE OVERWRAY BANDAGE NON-ELAS | Jan 27, 1984 | Substantially Equivalent |
| K833729 | ELASTIC BREATHABLE OVER-WRAP BANDAGE | Dec 30, 1983 | Substantially Equivalent |
| K833733 | NON - ADHERENT BANDAGE | Dec 27, 1983 | Substantially Equivalent |
| K833732 | NON WETTING UNDERCAST PADDING | Dec 12, 1983 | Substantially Equivalent |
| K830201 | POLYESTER X-RAY DETECTABLE STRUNG-SPONGE | Feb 23, 1983 | Substantially Equivalent |
| K830202 | COTTON BALLS, X-RAY OPAQUED STRUNG & NON | Feb 23, 1983 | Substantially Equivalent |
| K803116 | HEAVY DRAINAGE PACK | Jan 28, 1981 | Substantially Equivalent |
| K803115 | DRESSING CHANGE FOR G TUBE | Jan 6, 1981 | Substantially Equivalent |