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510(k) K801516

PRE-DENT SYSTEM MODIFIED by Pre-Dent System — Product Code KSS

K801516 is an FDA 510(k) premarket notification submitted by Pre-Dent System for the device "PRE-DENT SYSTEM MODIFIED". The FDA issued a decision of Substantially Equivalent on July 14, 1980. The device falls under product code KSS (Supplies, Blood-Bank), a Class I device regulated under 21 CFR 864.9050. Pre-Dent System has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1980
Date Received
July 1, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Supplies, Blood-Bank
Device Class
Class I
Regulation Number
864.9050
Review Panel
HE
Submission Type

Other clearances by Pre-Dent System

  • K801386 — PRE-DENT SYSTEM OR PRE-DENT II (July 14, 1980)
  • K800736 — PRE-DENT SYSTEM (April 24, 1980)

Other clearances for product code KSS

  • K874436 — FLUID SAMPLING PACK (January 5, 1988)
  • K812892 — S/P SERUM DROPPER PIPETS (October 27, 1981)
  • K801386 — PRE-DENT SYSTEM OR PRE-DENT II (July 14, 1980)
  • K800736 — PRE-DENT SYSTEM (April 24, 1980)
  • K761303 — IMMU-SAL IMMUNOHEMATOLOGICAL SALINE (December 30, 1976)

FDA data resources