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510(k) K884195

GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) by Mumtaz I. Malik — Product Code GEN

K884195 is an FDA 510(k) premarket notification submitted by Mumtaz I. Malik for the device "GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)". The FDA issued a decision of Substantially Equivalent on October 24, 1988. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Mumtaz I. Malik has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1988
Date Received
October 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Mumtaz I. Malik

  • K901511 — CHISEL, BONE, SURGICAL (September 28, 1990)
  • K901289 — RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS (September 28, 1990)
  • K901521 — OSTEOTOMES OF VARIOUS TYPES (September 28, 1990)
  • K901420 — VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8 (September 28, 1990)
  • K893902 — 4 X 4 STERILE GAUZE SPONGE TRAY (July 14, 1989)
  • K890071 — STERILE LACERATION TRAY (January 24, 1989)

Other clearances for product code GEN

  • K031828 — NATURALASE LP ND:YAG LASER (July 17, 2003)
  • K953962 — FORCEPS (September 8, 1995)
  • K932385 — SUTURE REMOVING FORCEPS (August 6, 1993)
  • K904723 — FORCEPS (July 26, 1991)
  • K911159 — PALPATION PROBE (March 29, 1991)
  • K900952 — GS-1200 GRASPING/EXTRACTING FORCEP, 10MM (April 18, 1990)
  • K900951 — GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP (April 18, 1990)
  • K900960 — GS-1500 CLAW FORCEP, 10MM (April 18, 1990)
  • K900948 — GS-1002 GRASPING FORCEP, 5MM WITH RATCHET (April 18, 1990)
  • K891896 — TISSUE FORCEPS, VARIOUS TYPES (April 12, 1989)

FDA data resources