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510(k) K832149

PDM SILOXANE PROSTHETIC OBTURATOR by Delaware Prosthetics, Inc.

K832149 is an FDA 510(k) premarket notification submitted by Delaware Prosthetics, Inc. for the device "PDM SILOXANE PROSTHETIC OBTURATOR". The FDA issued a decision of Substantially Equivalent on November 28, 1983. Delaware Prosthetics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1983
Date Received
July 5, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Delaware Prosthetics, Inc.

  • K832151 — PDM SILOXANE PROSTHETIC ORBIT (December 19, 1983)
  • K832153 — PDM SILOXANE PROSTHETIC NOSE (December 9, 1983)
  • K832152 — PDM SILOXANE PROSTHETIC EAR (December 9, 1983)
  • K832148 — PDM SILOXANE PROSTHETIC CHIN IMPLANT (November 28, 1983)

FDA data resources