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510(k) K780399

INSTRUMENT CLEANING BRUSH by Ransom and Randolph — Product Code KDC

K780399 is an FDA 510(k) premarket notification submitted by Ransom and Randolph for the device "INSTRUMENT CLEANING BRUSH". The FDA issued a decision of Substantially Equivalent on March 17, 1978. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. Ransom and Randolph has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1978
Date Received
March 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ransom and Randolph

  • K781605 — R&R ABSORBENT POINTS (October 10, 1978)
  • K780198 — PROPHY CUPS, R&R (February 16, 1978)
  • K780199 — PROPHY ANGLES, R&R (February 16, 1978)
  • K771347 — R&R ALSTON CARBIDE BURS (August 3, 1977)
  • K770598 — ENDODONTIC INSTRUMENTS, R&R CUTWELL (April 5, 1977)
  • K761067 — DENTSPLY DIE STONE (November 30, 1976)

Other clearances for product code KDC

  • K943229 — DISPOSABLE SURGICAL SCISSORS AND FORCEPS (August 19, 1994)
  • K936226 — SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET (March 7, 1994)
  • K920153 — THERMUFF BAG (July 1, 1992)
  • K920263 — MANUAL SURGICAL INSTRUMENTS (May 6, 1992)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K914960 — INSTRUMENT ORGANIZER (February 28, 1992)
  • K912834 — SHUR-GRIP (July 26, 1991)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)

FDA data resources