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510(k) K944177

BREAST SHELL by O'Donnell, Byrne & Williams — Product Code HFS

K944177 is an FDA 510(k) premarket notification submitted by O'Donnell, Byrne & Williams for the device "BREAST SHELL". The FDA issued a decision of Substantially Equivalent on October 5, 1994. The device falls under product code HFS (Shield, Nipple), a Class I device regulated under 21 CFR 880.5630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1994
Date Received
August 26, 1994
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 for product code HFS

  • 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)
  • K833450 — NUK BREAST SHIELD (November 21, 1983)

FDA data resources