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510(k) K974442

PRE-POWDERED NITRILE EXAMINATION GLOVES by P.T. Latexindo Tobaperkasa — Product Code LZY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1998
Date Received
November 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by P.T. Latexindo Tobaperkasa

  • K974443 — POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED (January 5, 1998)
  • K972539 — Hi Coat Powder Free Latex Patient Examination Gloves (November 18, 1997)

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  • K915548 — IONGUARD TITANIUM MODULAR HEADS (March 10, 1992)
  • K903084 — MODULAR CATHCART FRACTURE SYSTEM (October 3, 1990)
  • K896580 — UNI-POLAR HEAD (February 15, 1990)
  • K892059 — FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR (July 19, 1989)