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510(k) K780771

MICRO RASPS by Amsco Co. — Product Code HTR

K780771 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "MICRO RASPS". The FDA issued a decision of Substantially Equivalent on May 16, 1978. The device falls under product code HTR (Rasp), a Class I device regulated under 21 CFR 878.4800. Amsco Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1978
Date Received
May 5, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rasp
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Amsco Co.

  • K912471 — EAGLE 3000 SDS (June 26, 1992)
  • K854922 — AMSCO POLARIS SL (January 24, 1986)
  • K833187 — HALL OSTEON (October 31, 1983)
  • K832945 — EAGLE 2000 STERILIZER SERIES GAS/AERA (October 19, 1983)
  • K832186 — HALL DRILL/REAMER (August 12, 1983)
  • K832188 — HALL RECIPROCATOR (August 12, 1983)
  • K832187 — HALL OSCILLATOR (August 12, 1983)
  • K831086 — CEILING MOUNTED SUPPORT (August 12, 1983)
  • K831309 — DELIVERY 4 TABLE (June 15, 1983)
  • K823360 — SURGICAL LIGHT (December 3, 1982)

Other clearances for product code HTR

  • K870329 — ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 (February 13, 1987)
  • K870349 — BIODYNAMICS FEMORAL CANAL BRUSH #1201 (February 13, 1987)
  • K870333 — BIODYNAMICS SMALL JOINT BRUSH #1203 (February 13, 1987)
  • K813093 — RICHARDS ACETABULAR BRUSH (November 20, 1981)
  • K812506 — THE ARTHROFILE (September 24, 1981)
  • K771016 — INTERMEDULLARY BRUSH (January 12, 1978)
  • K771745 — RASPS FOR SCRAPING BONE (September 28, 1977)
  • K760109 — PROSTHESIS, TOTAL HIP-RASP (July 20, 1976)

FDA data resources