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510(k) K930238

BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS by Prolac, Inc. — Product Code HFS

K930238 is an FDA 510(k) premarket notification submitted by Prolac, Inc. for the device "BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS". The FDA issued a decision of Substantially Equivalent on August 16, 1993. 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
August 16, 1993
Date Received
January 19, 1993
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)
  • K944177 — BREAST SHELL (October 5, 1994)
  • K935340 — COMFORT PLUS NIPPLE SHIELDS (January 21, 1994)
  • K935341 — COMFORT PLUS BREAST SHELLS (January 21, 1994)
  • 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