Home / 510(k) Clearances / K861608

510(k) K861608

UNICARE BREAST SHELLS by Unicare Medical Products, Inc. — Product Code HFS

K861608 is an FDA 510(k) premarket notification submitted by Unicare Medical Products, Inc. for the device "UNICARE BREAST SHELLS". The FDA issued a decision of Substantially Equivalent on July 15, 1986. 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
July 15, 1986
Date Received
April 29, 1986
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)
  • 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