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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 Nov 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
Nov 21, 1983
Date Received
Oct 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
510(k) Exempt

Other clearances for product code HFS

  • K944177 — BREAST SHELL (Oct 5, 1994)
  • K944117 — AVENT NIPPLE SHIELD (Oct 5, 1994)
  • K935341 — COMFORT PLUS BREAST SHELLS (Jan 21, 1994)
  • K935340 — COMFORT PLUS NIPPLE SHIELDS (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)

FDA data resources

Source: FDA 510(k) database entry for K833450. Report a data issue: hello@regdatalab.com.