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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 Oct 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
Oct 5, 1994
Date Received
Aug 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
510(k) Exempt

Other clearances for product code HFS

  • K944117 — AVENT NIPPLE SHIELD (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)
  • K840877 — ARGYLE ENTERNAL FEEDING BAG W/ADMIN (Jun 28, 1984)
  • K833450 — NUK BREAST SHIELD (Nov 21, 1983)

FDA data resources

Source: FDA 510(k) database entry for K944177. Report a data issue: hello@regdatalab.com.