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510(k) K921917

DOLOMITE ROLLATOR by Seamark Technologies — Product Code INM

K921917 is an FDA 510(k) premarket notification submitted by Seamark Technologies for the device "DOLOMITE ROLLATOR". The FDA issued a decision of Substantially Equivalent on May 26, 1992. The device falls under product code INM (Chair, With Casters), a Class I device regulated under 21 CFR 890.3100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1992
Date Received
April 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, With Casters
Device Class
Class I
Regulation Number
890.3100
Review Panel
PM
Submission Type

Other clearances for product code INM

  • K063521 — NISSIN PEDIATRIC SERIES WHEELCHAIR (February 5, 2007)
  • K941738 — STRYKER 5050 STRECHAIR (May 6, 1994)
  • K941569 — CAREMOR CLINER (April 26, 1994)
  • K933000 — RECLINING GERI CHAIRS W/CASTERS & LAP TRAY (September 30, 1993)
  • K926028 — BENCHES (March 24, 1993)
  • K926053 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K926025 — CHAIRS (March 22, 1993)
  • K926054 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K924848 — KAYE SCOOT-ABOUT, MODEL SB1 (February 12, 1993)
  • K925247 — STONEHEART ROLLER AID (February 12, 1993)

FDA data resources