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510(k) K811364

AXICARE BREAST SHELL by Neonatal Corp. — Product Code HFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1981
Date Received
May 14, 1981
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 Neonatal Corp.

  • K811707 — AXICUT DISPOSABLE SCALPEL (July 20, 1981)
  • K811403 — AXICARE BREAST PUMP MODEL (June 12, 1981)

Other clearances for product code HFS

  • K944177 — BREAST SHELL (October 5, 1994)
  • K944117 — AVENT NIPPLE SHIELD (October 5, 1994)
  • K935341 — COMFORT PLUS BREAST SHELLS (January 21, 1994)
  • K935340 — COMFORT PLUS NIPPLE SHIELDS (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)
  • K840877 — ARGYLE ENTERNAL FEEDING BAG W/ADMIN (June 28, 1984)