FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PARAPLAST EXTRA TISSUE EMBEDDING MED.
K Number: K842053
·
Decision Jun 26, 1984
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
10
Applicant Total
191
Review Days
35
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Basic Information
- Device Name
- PARAPLAST EXTRA TISSUE EMBEDDING MED.
- K Number
- K842053
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Co.
- Date Received
- May 22, 1984
- Decision Date
- June 26, 1984
- Product Code
- KEO
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KEO | Formulations, Paraffin, All | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KEO), ordered by most recent decision date.
TISSUE EMBEDDING MEDIUM
FDA 510(k)
FDA Class 1
·Pathology
MICRO THIN* PARAFFIN
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FDA Class 1
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HISTOLOGY PARAFFIN
FDA 510(k)
FDA Class 1
·Pathology
BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED.
FDA 510(k)
FDA Class 1
·Pathology
TECHNICON PARACUT
FDA 510(k)
FDA Class 1
·Pathology
PARAFFIN INFILTRATION MEDIUM
FDA 510(k)
FDA Class 1
·Pathology
Other Clearances by Sherwood Medical Co.
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|---|---|---|---|
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| K960574 | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM | Aug 5, 1996 | Substantially Equivalent |
| K960677 | KANGAROO JEJUNAL FEEDING SYSTEM | May 13, 1996 | Substantially Equivalent |
| K960632 | KANGAROO FEEDING TUBE PLACMENT STYLET | May 9, 1996 | Substantially Equivalent |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Mar 28, 1996 | Substantially Equivalent |
| K954429 | KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT | Mar 8, 1996 | Unknown |
| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Jan 19, 1996 | Substantially Equivalent |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Dec 15, 1995 | Substantially Equivalent |