FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COTTON NEUROLOGICAL SPONGE
K Number: K854713
·
Decision Mar 20, 1986
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
23
Applicant Total
14
Review Days
118
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Basic Information
- Device Name
- COTTON NEUROLOGICAL SPONGE
- K Number
- K854713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4700
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- American Silk Sutures, Inc.
- Date Received
- November 22, 1985
- Decision Date
- March 20, 1986
- Product Code
- HBA
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBA | Neurosurgical Paddie | FDA class 2 | Neurology |
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Other Clearances by American Silk Sutures, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922143 | AMERICAN BURN SHEET | Aug 10, 1992 | Substantially Equivalent |
| K904514 | STRUNG TELFA NON-ADHERENT SPONGE | Mar 27, 1991 | Substantially Equivalent |
| K902921 | RAYON NEUROLOGICAL SPONGE | Sep 18, 1990 | Substantially Equivalent |
| K872810 | STRUNG DENTAL ROLLS | Dec 4, 1987 | Substantially Equivalent |
| K872951 | AMERICAN BRAIN RETRACTOR COVER | Sep 16, 1987 | Substantially Equivalent |
| K872905 | AMERICAN NASAL SPONGE | Sep 4, 1987 | Substantially Equivalent |
| K872906 | SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE | Aug 11, 1987 | Substantially Equivalent |
| K872809 | GAUZE CHERRY SPONGE | Aug 4, 1987 | Substantially Equivalent |
| K872808 | CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8 | Aug 4, 1987 | Substantially Equivalent |
| K872806 | STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG | Aug 4, 1987 | Substantially Equivalent |