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510(k) K842053

PARAPLAST EXTRA TISSUE EMBEDDING MED. by Sherwood Medical Co. — Product Code KEO

K842053 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "PARAPLAST EXTRA TISSUE EMBEDDING MED.". The FDA issued a decision of Substantially Equivalent on June 26, 1984. The device falls under product code KEO (Formulations, Paraffin, All), a Class I device regulated under 21 CFR 864.4010. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1984
Date Received
May 22, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formulations, Paraffin, All
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Sherwood Medical Co.

  • K981365 — MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS (November 25, 1998)
  • K960982 — MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. A (December 23, 1996)
  • K962880 — SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM (December 9, 1996)
  • K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC C (August 5, 1996)
  • K960677 — KANGAROO JEJUNAL FEEDING SYSTEM (May 13, 1996)
  • K960632 — KANGAROO FEEDING TUBE PLACMENT STYLET (May 9, 1996)
  • K955831 — ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (March 28, 1996)
  • K954429 — KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT (March 8, 1996)
  • K954525 — SENSI-TOUCH EPIDURAL ANESTHESIA FILTER (January 19, 1996)
  • K950201 — ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER (December 15, 1995)

Other clearances for product code KEO

  • K893772 — TISSUE EMBEDDING MEDIUM (June 22, 1989)
  • K862223 — MICRO THIN* PARAFFIN (June 17, 1986)
  • K862141 — HISTOLOGY PARAFFIN (June 13, 1986)
  • K861270 — BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. (April 11, 1986)
  • K833071 — TECHNICON PARACUT (October 14, 1983)
  • K831580 — PARAFFIN INFILTRATION MEDIUM (June 17, 1983)
  • K812191 — VASPAR SEALENT (August 31, 1981)
  • K810568 — PARAFFIN EMBEDDING MEDIUM (March 17, 1981)
  • K803241 — HISTOLOGICAL EMBEDDING MEDIA (January 28, 1981)
  • K760602 — SORVALL EMBEDDING MEDIUM (September 21, 1976)

FDA data resources