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510(k) K833450

NUK BREAST SHIELD by Reliance Products Corp. — Product Code HFS

K833450 is an FDA 510(k) premarket notification submitted by Reliance Products Corp. for the device "NUK BREAST SHIELD". The FDA issued a decision of Substantially Equivalent on November 21, 1983. 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
November 21, 1983
Date Received
October 5, 1983
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)
  • 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