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510(k) K932513

LABELING FOR MYO/WIRE II STERNOTOMY SUTURES by Alto Development Corp. — Product Code GAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1994
Date Received
May 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable
Device Class
Class II
Regulation Number
878.4495
Review Panel
SU
Submission Type

Other clearances by Alto Development Corp.

  • K964621 — A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON (December 20, 1996)
  • K931537 — A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT (September 7, 1993)
  • K930528 — A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS (May 17, 1993)
  • K914193 — A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT (October 5, 1992)
  • K915300 — A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES (February 18, 1992)
  • K884783 — RANEY CLIP (November 30, 1988)
  • K881413 — ELECTRO-CAUTERY SUCTION TUBE (April 21, 1988)
  • K831867 — PRESSURE MONITORING IV BOTTLE CAP (August 12, 1983)
  • K821518 — MYO/CLIP (July 8, 1982)

Other clearances for product code GAO

  • K872532 — AUTO SUTURE STAINLESS STEEL SUTURES* (August 5, 1987)
  • K863034 — SHARPOINT STAINLESS STEEL SUTURE (September 30, 1986)
  • K802248 — DISARP ORIGINAL (September 26, 1980)