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510(k) K894618

INAMED RHEMO-D (TM) DILATOR by Inamed Development Co. — Product Code FFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1990
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Rectal
Device Class
Class I
Regulation Number
876.5450
Review Panel
GU
Submission Type

Other clearances by Inamed Development Co.

  • K931548 — INAMED DEVELOPMENT ASPIRATION TIP (January 10, 1994)
  • K904265 — INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER (March 6, 1991)
  • K901742 — INAMED SMALL DRAIN SYSTEM (May 7, 1990)
  • K901764 — INAMED CONVERTIBLE DRAIN SYSTEM (May 7, 1990)
  • K896491 — INAMED CLOSED-WOUND DRAIN SYSTEM (January 8, 1990)
  • K894073 — INAMED PRO-TEC SILICONE SURGICAL GLOVES (September 18, 1989)

Other clearances for product code FFP

  • K964634 — ANOKRYO (June 6, 1997)
  • K901426 — COLONIC BALLOON DILATOR (June 21, 1990)
  • K884713 — COLONIC BALLOON DIALATORS (September 29, 1989)
  • K830354 — COLORECTAL DILATOR (May 27, 1983)