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510(k) K922128

HOSPITAL KIT EP 104 by Savoy Medical Supply Co., Inc. — Product Code MDM

K922128 is an FDA 510(k) premarket notification submitted by Savoy Medical Supply Co., Inc. for the device "HOSPITAL KIT EP 104". The FDA issued a decision of Substantially Equivalent (kit) on March 23, 1993. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Savoy Medical Supply Co., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 23, 1993
Date Received
May 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Savoy Medical Supply Co., Inc.

  • K922133 — HOSPITAL KIT SV 105 (June 7, 1993)
  • K922130 — HOSPITAL KIT DK 117 (May 24, 1993)
  • K922127 — HOSPITAL KIT GP 103 (March 29, 1993)
  • K923281 — SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT (March 26, 1993)
  • K922126 — HOSPITAL KIT ENT 1125 (January 21, 1993)
  • K923283 — SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT (January 4, 1993)

Other clearances for product code MDM

  • K073664 — FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER (August 8, 2008)
  • K050575 — FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM (August 15, 2005)
  • K050957 — EUTROCHAR (May 18, 2005)
  • K023173 — ANDREWS INTRODUCER, MODEL ASI01 (December 18, 2002)
  • K022059 — MICROVASIVE PULMONARY GUIDEWIRE (November 13, 2002)
  • K013040 — LIGHT SABER INTRODUCER NEEDLE (December 7, 2001)
  • K010184 — CHESS HAND SURGERY SYSTEM (June 22, 2001)
  • K990062 — SAPHLIFT (March 30, 1999)
  • K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (July 9, 1998)
  • K943968 — TUNNELER (March 1, 1995)

FDA data resources