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510(k) K994361

ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL by Genesis Industries, Inc. — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2000
Date Received
December 27, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type

Other clearances by Genesis Industries, Inc.

  • K962828 — EVERT-IT (February 10, 1997)
  • K880377 — NOVO VIVO MODEL #17140 AND #17135 (April 4, 1988)
  • K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (February 16, 1988)
  • K833290 — C & B 40 PENTRO C & B40 (January 3, 1984)
  • K833287 — SATIN CAST ECONOCAST (January 3, 1984)
  • K833289 — C & B 61 PENTRON C & B61 (December 29, 1983)
  • K833278 — C & B 45 (December 29, 1983)
  • K833280 — SUPRA AP CHOICE 83 (December 26, 1983)
  • K833285 — RX IV PENTRON IV (December 22, 1983)
  • K833288 — C & B57 PENTRON C & B57 (December 20, 1983)

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