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510(k) K915393

MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE by Mdt Corp., Inc. — Product Code GDC

K915393 is an FDA 510(k) premarket notification submitted by Mdt Corp., Inc. for the device "MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE". The FDA issued a decision of Substantially Equivalent on December 17, 1991. The device falls under product code GDC (Table, Operating-Room, Electrical), a Class I device regulated under 21 CFR 878.4960. Mdt Corp., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1991
Date Received
November 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Electrical
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

Other clearances by Mdt Corp., Inc.

  • K960777 — MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR (May 23, 1996)
  • K942485 — MDT UROLOGY TABLE (August 26, 1994)
  • K942486 — IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE (August 10, 1994)
  • K924380 — MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE (February 16, 1994)
  • K926081 — DENTAL LIGHT (January 26, 1994)
  • K924955 — MDT/HARVEY MC-8 AND MC-10 (October 15, 1993)
  • K932094 — BOVIE ULTRASONIC SURGICAL ASPIRATOR (July 21, 1993)
  • K931169 — MDT DENTAL CHAIR (May 20, 1993)
  • K920930 — MDT/CASTLE 10/90 DUAL LOAD STATION (March 31, 1993)
  • K922212 — MDT CASTLE BIOSIGN TEST PACK (August 10, 1992)

Other clearances for product code GDC

  • K971390 — QUANTUM 3080SP SURGICAL TABLE (May 15, 1997)
  • K970807 — MOBILE OPERATING TABLE 1132.01 (March 14, 1997)
  • K964273 — DURA-BOARD ARMBOARD (January 8, 1997)
  • K940616 — SKYTRON ELITE 3500 TABLE (June 13, 1994)
  • K934744 — MIDMARK MAGNUM GENERAL SURGICAL TABLE (March 28, 1994)
  • K914758 — MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE (December 19, 1991)
  • K883613 — OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. (September 15, 1988)
  • K853720 — MOBILE OPERATING TABLE FOR ORL MICROSURGERY (October 18, 1985)
  • K853480 — SKYTRON ELITE 6000 & 6001 SURGICAL TABLES (September 12, 1985)
  • K853535 — TRAUMA TABLE (September 11, 1985)

FDA data resources