FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
WET DRESSING SALINE-STERILE
K Number: K844096
·
Decision Nov 19, 1984
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
10
Review Days
27
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Basic Information
- Device Name
- WET DRESSING SALINE-STERILE
- K Number
- K844096
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Absorbent Cotton Co., Inc.
- Date Received
- October 23, 1984
- Decision Date
- November 19, 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 Absorbent Cotton Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883250 | STERI-CLENS WOUND CARE KIT | Aug 26, 1988 | Substantially Equivalent |
| K880613 | ACCO(R) FACE MASK | Mar 4, 1988 | Substantially Equivalent |
| K875129 | STERI-CLENS | Feb 18, 1988 | Substantially Equivalent |
| K874741 | STERI-CLENS(TM) SURGICAL SCRUB SPONGE | Dec 10, 1987 | Substantially Equivalent |
| K873523 | PLAIN DRY GAUZE | Oct 9, 1987 | Substantially Equivalent |
| K854740 | PRIMADERM | Mar 14, 1986 | Substantially Equivalent for Some Indications |
| K850126 | OIL EMULSION NON-ADHERING DRESSING | Apr 25, 1985 | Substantially Equivalent |
| K844095 | WET DRESSING WATER-STERILE | Nov 27, 1984 | Substantially Equivalent |
| K781727 | CHANGE IN STERILIZATION PROCEDURE | Dec 4, 1978 | Substantially Equivalent |