FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERI-CLENS(TM) SURGICAL SCRUB SPONGE
K Number: K874741
·
Decision Dec 10, 1987
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
36
Applicant Total
10
Review Days
17
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Basic Information
- Device Name
- STERI-CLENS(TM) SURGICAL SCRUB SPONGE
- K Number
- K874741
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Absorbent Cotton Co., Inc.
- Date Received
- November 23, 1987
- Decision Date
- December 10, 1987
- Product Code
- GEC
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEC | Brush, Scrub, Operating-Room | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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STERILE SCRUBBY SCRUB BRUSH
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STERI-CLENS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| 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 |
| K844096 | WET DRESSING SALINE-STERILE | Nov 19, 1984 | Substantially Equivalent |
| K781727 | CHANGE IN STERILIZATION PROCEDURE | Dec 4, 1978 | Substantially Equivalent |