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510(k) K982258

MAMMARY SIZER by Specialty Surgical Products, Inc. — Product Code MRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1998
Date Received
June 26, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mammary Sizer
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Specialty Surgical Products, Inc.

  • K140383 — ALLOX2 TISSUE EXPANDERS (October 28, 2014)
  • K070303 — SILICONE TISSUE EXPANDER (June 22, 2007)
  • K984106 — MAMMARY SIZER, MAMMARY PROTHESIS SIZER (February 12, 1999)
  • K983015 — VIRILIS PENILE PROSTHESIS (February 5, 1999)
  • K982065 — STERILE SILICONE EXTERNAL WOUND COVER (August 12, 1998)
  • K982067 — MAGNETIC PORT SILICONE TISSUE EXPANDER (July 13, 1998)
  • K974653 — SILICONE ELASTOMER SHEETING (March 13, 1998)
  • K974654 — SILICONE BLOCKS (February 24, 1998)
  • K974209 — SILICONE TISSUE/INFLATABLE TISSUE EXPANDER (February 6, 1998)
  • K973656 — DISPOSABLE SILICONE EPISTAXIS CATHETER (November 18, 1997)

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