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510(k) K811364

AXICARE BREAST SHELL by Neonatal Corp. — Product Code HFS

K811364 is an FDA 510(k) premarket notification submitted by Neonatal Corp. for the device "AXICARE BREAST SHELL". The FDA issued a decision of Substantially Equivalent on August 3, 1981. The device falls under product code HFS (Shield, Nipple), a Class I device regulated under 21 CFR 880.5630. Neonatal Corp. has at least 2 other 510(k) clearances on record.

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

  • 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)
  • K840877 — ARGYLE ENTERNAL FEEDING BAG W/ADMIN (June 28, 1984)

FDA data resources