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510(k) K840877

ARGYLE ENTERNAL FEEDING BAG W/ADMIN by Sherwood Medical Co. — Product Code HFS

K840877 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "ARGYLE ENTERNAL FEEDING BAG W/ADMIN". The FDA issued a decision of Substantially Equivalent on June 28, 1984. The device falls under product code HFS (Shield, Nipple), a Class I device regulated under 21 CFR 880.5630. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1984
Date Received
February 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Nipple
Device Class
Class I
Regulation Number
880.5630
Review Panel
HO
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 HFS

  • K944117 — AVENT NIPPLE SHIELD (October 5, 1994)
  • K944177 — BREAST SHELL (October 5, 1994)
  • K935340 — COMFORT PLUS NIPPLE SHIELDS (January 21, 1994)
  • K935341 — COMFORT PLUS BREAST SHELLS (January 21, 1994)
  • K930238 — BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS (August 16, 1993)
  • K923577 — BREAST SHELLS (January 22, 1993)
  • K864176 — GENTLE FEEL (November 4, 1986)
  • K861608 — UNICARE BREAST SHELLS (July 15, 1986)
  • K853176 — CANNON BABYSAFE NIPPLE SHIELDS (August 22, 1985)
  • K833450 — NUK BREAST SHIELD (November 21, 1983)

FDA data resources