Home / 510(k) Clearances / K861928

510(k) K861928

STERILE O. R. TOWEL by Anago, Inc. — Product Code IXX

K861928 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "STERILE O. R. TOWEL". The FDA issued a decision of Substantially Equivalent on June 9, 1986. The device falls under product code IXX (Processor, Cine Film), a Class II device regulated under 21 CFR 892.1900. Anago, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1986
Date Received
May 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Cine Film
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type

Other clearances by Anago, Inc.

  • K925659 — U.C.E.Z. LENS CLEANER KIT (September 17, 1993)
  • K930161 — ANAGO SPINAL ANESTHESIA TRAY (July 6, 1993)
  • K926589 — ANAGO WARM PACK (May 26, 1993)
  • K926590 — ANAGO DISPOSABLE INSTANT COLD PACK (May 26, 1993)
  • K926137 — ANAGO FEM-COOL/FEM-COOL PETITE (May 26, 1993)
  • K920615 — ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT (March 20, 1993)
  • K915415 — GUARDALL SHIELD (October 15, 1992)
  • K913558 — RELIABLE CONE STYLE FACE MASK (November 7, 1991)
  • K905865 — ANTI-FOR SURGICAL FACE MASK (March 6, 1991)
  • K905749 — SURGICAL FACE MASK (March 4, 1991)

Other clearances for product code IXX

  • K963334 — JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 (September 11, 1996)
  • K915365 — AP-6CR CINERADIOGRAPHIC FILM PROCESSOR (August 27, 1992)
  • K913241 — JAMIESON JT-CRP CINE FILM PROCESSOR (September 24, 1991)
  • K850421 — CINE RADIOGRAPHIC FILM PROCESSOR M-45CR (March 22, 1985)
  • K841431 — RADIOGRAPHIC FILM PROCESSOR M-30CR & (July 6, 1984)

FDA data resources