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510(k) K770158

HEMOSTAT by Deringer-Ney, Inc. — Product Code EMD

K770158 is an FDA 510(k) premarket notification submitted by Deringer-Ney, Inc. for the device "HEMOSTAT". The FDA issued a decision of Substantially Equivalent on January 31, 1977. The device falls under product code EMD (Hemostat, Surgical), a Class I device regulated under 21 CFR 872.4565. Deringer-Ney, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1977
Date Received
January 24, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostat, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Deringer-Ney, Inc.

  • K933178 — GDC 3509 (October 14, 1993)
  • K930482 — DENTAL CASTING ALLOY, MODIFICATION - PF-3 (March 31, 1993)
  • K930481 — DENTAL CASTING ALLOY MODIFICATION-PF-4 (March 31, 1993)
  • K925273 — GDC 3445 (December 21, 1992)
  • K920922 — GDC 3367 (May 5, 1992)
  • K920060 — DENTAL SOLDER ALLOY (April 2, 1992)
  • K920887 — GDC-3338, DENTAL SOLDER ALLOY (March 19, 1992)
  • K910065 — GDC-3200 DENTAL SOLDER (March 15, 1991)
  • K904695 — GDC-1501 (January 2, 1991)
  • K904614 — GDC-1475 (December 19, 1990)

Other clearances for product code EMD

  • K920883 — HEMOSTAT, SURGICAL (VARIOUS TYPES) (March 13, 1992)

FDA data resources