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510(k) K801513

TISSUE PROCESSING SYSTEM by Innovative Medical Systems, Inc. — Product Code IEO

K801513 is an FDA 510(k) premarket notification submitted by Innovative Medical Systems, Inc. for the device "TISSUE PROCESSING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code IEO (Processor, Tissue, Automated), a Class I device regulated under 21 CFR 864.3875. Innovative Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
June 30, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Tissue, Automated
Device Class
Class I
Regulation Number
864.3875
Review Panel
PA
Submission Type

Other clearances by Innovative Medical Systems, Inc.

  • K973035 — VIOLA II DENTAL CAMERA SYSTEM (September 24, 1997)
  • K951469 — BAZOOKA SYSTEM (June 28, 1995)
  • K933184 — POSITIVE AIRWAY PRESSURE SYSTEM (November 28, 1994)
  • K924590 — MICROWAVE AUTOMATED TISSUE PROCESSOR (December 29, 1992)
  • K922081 — LABOTECH AUTOMATED MICROTITER ANALYZER (September 2, 1992)
  • K921005 — AUTOLOADER (April 29, 1992)
  • K915457 — PHACO 20/20 SYSTEM I (February 24, 1992)
  • K915456 — PHACO 3000 LINEAR (February 12, 1992)
  • K883599 — LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (September 2, 1988)
  • K880745 — LX-100 SLIDE STAINER (April 27, 1988)

Other clearances for product code IEO

  • K924590 — MICROWAVE AUTOMATED TISSUE PROCESSOR (December 29, 1992)
  • K883599 — LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (September 2, 1988)
  • K881165 — SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR (July 1, 1988)
  • K853938 — LX 300 TISSUE PROCESSOR (October 10, 1985)
  • K851054 — LX120 TISSUE PROCESSOR (May 15, 1985)
  • K843506 — LKB 2189 ULTROPROCESSOR (November 30, 1984)
  • K834599 — AUTOTECHNICON V TISSUE PROCESS SYS (February 4, 1984)
  • K831313 — TISSUE-TEK V.I.P. 100/200 (July 28, 1983)
  • K801427 — TISSUE-TEK III MINI-RAPID PROCESSOR (July 28, 1980)
  • K771308 — TISSUE-TEK III V.I.P. (August 22, 1977)

FDA data resources