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510(k) K880318

ROVENSTEIN FORCEPS by Eastmed Enterprises, Inc. — Product Code BWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1988
Date Received
January 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Tube Introduction
Device Class
Class I
Regulation Number
868.5780
Review Panel
AN
Submission Type

Other clearances by Eastmed Enterprises, Inc.

  • K922019 — LARYNGOSCOPE RIGID (January 26, 1993)
  • K921128 — ENDOTRACHEAL TUBE STYLET (June 2, 1992)
  • K914741 — AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED (February 3, 1992)
  • K903618 — ROBERTAZZI NASOPHARYNGEAL AIRWAY (January 8, 1991)
  • K901489 — MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE) (April 10, 1990)
  • K890342 — AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) (April 27, 1989)
  • K884584 — TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS (November 14, 1988)
  • K884073 — LARYNGOSCOPE BLADE (ROBERTSHAW STYLE) (October 13, 1988)
  • K884072 — 15 MILLIMETER MALE AND FEMALE ADAPTERS (October 7, 1988)
  • K882433 — LARYNGOSCOPE RIGID (September 2, 1988)

Other clearances for product code BWB

  • K884584 — TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS (November 14, 1988)
  • K880319 — MAGILL FORCEPS (March 21, 1988)
  • K840313 — CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV (February 4, 1984)
  • K834169 — OP-CON SURGICAL INSTRUMENT #9 (January 17, 1984)
  • K820451 — INTRODUCER FOR ENDOTRACHEAL TUBE (March 26, 1982)