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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 Jun 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 190 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 28, 1984
Date Received
Feb 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
510(k) Exempt

Other clearances by Sherwood Medical Co.

  • K981365 — MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS (Nov 25, 1998)
  • K960982 — MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V… (Dec 23, 1996)
  • K962880 — SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM (Dec 9, 1996)
  • K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC… (Aug 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 (Mar 28, 1996)
  • K954429 — KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT (Mar 8, 1996)
  • K954525 — SENSI-TOUCH EPIDURAL ANESTHESIA FILTER (Jan 19, 1996)
  • K950201 — ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER (Dec 15, 1995)

Other clearances for product code HFS

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

FDA data resources

Source: FDA 510(k) database entry for K840877. Report a data issue: hello@regdatalab.com.