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510(k) K871615

U. V. GERMICIDAL UNIT by Lorvic Corp. — Product Code KMH

K871615 is an FDA 510(k) premarket notification submitted by Lorvic Corp. for the device "U. V. GERMICIDAL UNIT". The FDA issued a decision of Substantially Equivalent on September 11, 1987. The device falls under product code KMH (Sterilizer, Dry Heat), a Class II device regulated under 21 CFR 880.6870. Lorvic Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1987
Date Received
April 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Dry Heat
Device Class
Class II
Regulation Number
880.6870
Review Panel
HO
Submission Type

Other clearances by Lorvic Corp.

  • K780263 — SHIELD (May 3, 1978)
  • K770064 — FLUORIDE GEL DISPOSABLE TRAY (January 14, 1977)
  • K770063 — DISP. ABSORBENT COMPRESSED FIBRE WAFER (January 14, 1977)
  • K760620 — SALIVA EJECTOR (September 21, 1976)
  • K760121 — IMPULSE HEAT SEALER (July 16, 1976)

Other clearances for product code KMH

  • K094026 — STERI-DENT, STERI-SURE (July 12, 2011)
  • K051660 — DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM (August 4, 2005)
  • K910925 — DISINFECTION WITH THE COX DRY HEAT STERILIZER (May 8, 1992)
  • K910202 — DENTRONIX MODEL 2000 (March 13, 1991)
  • K880322 — DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM (July 13, 1988)
  • K881371 — COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE (April 13, 1988)
  • K872643 — COX RAPID HEAT TRANSFER STERILIZER (October 29, 1987)
  • K851307 — INOX DRY HEAT STERILIZER (May 9, 1985)
  • K771070 — DRY HEAT STERILIZER (July 14, 1977)

FDA data resources