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510(k) K830111

SEPTOCAL by North Pacific Dental, Inc.

K830111 is an FDA 510(k) premarket notification submitted by North Pacific Dental, Inc. for the device "SEPTOCAL". The FDA issued a decision of Substantially Equivalent on March 24, 1983. North Pacific Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
January 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by North Pacific Dental, Inc.

  • K830113 — SEPTOPACK (May 9, 1983)
  • K830106 — UNICIDE (March 7, 1983)
  • K830115 — PAPER POINTS (March 1, 1983)
  • K830109 — CIMPAT (March 1, 1983)
  • K830105 — VITATHYL (March 1, 1983)
  • K830117 — ENDOMET (March 1, 1983)
  • K830114 — GUTTA PERCHA POINTS (March 1, 1983)
  • K830107 — SELFAST (February 18, 1983)
  • K830116 — SULCARINGS (February 18, 1983)
  • K830112 — HYDROL (February 18, 1983)

FDA data resources