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510(k) K770898

FRACTURE CAST BRACE KIT, PLASTIC by Chase Mfg. Co. — Product Code HSP

K770898 is an FDA 510(k) premarket notification submitted by Chase Mfg. Co. for the device "FRACTURE CAST BRACE KIT, PLASTIC". The FDA issued a decision of Substantially Equivalent on July 21, 1977. The device falls under product code HSP (Splint, Traction), a Class I device regulated under 21 CFR 888.5890. Chase Mfg. Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1977
Date Received
May 16, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Traction
Device Class
Class I
Regulation Number
888.5890
Review Panel
OR
Submission Type

Other clearances by Chase Mfg. Co.

  • K791513 — ADAMCO DUST COVER (October 11, 1979)
  • K790993 — INSTANT HOT & COLD PACKS (September 7, 1979)
  • K790644 — SUBMAX (April 26, 1979)
  • K780033 — MATTRESSES, CONDUCTIVE & COVERS (February 21, 1978)
  • K771792 — ENEMA SET (October 20, 1977)
  • K771791 — NEEDLE COUNTING (October 4, 1977)
  • K770899 — FRACTURE CAST BRACE, POLY (July 21, 1977)
  • K770900 — CAST BRWM, FRACTURE (July 21, 1977)
  • K770173 — STOCKINETTE (February 8, 1977)

FDA data resources