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510(k) K840315

CAT 11- GENERAL & PLASTIC SURGERY DEV by Imm Enterprises , Ltd. — Product Code HTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1984
Date Received
January 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Imm Enterprises , Ltd.

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  • K841387 — WESTON RECTAL SNARE (May 9, 1984)
  • K840304 — CATEGORY 17-MICROBIOLOGY DEVICES (May 1, 1984)
  • K840305 — CATEGORY 1 CIRCULATORY SYSTEM DEVICE (April 23, 1984)
  • K840318 — CAT. 14-CLINICAL TOXIOLOGY DEVICES (April 23, 1984)
  • K840312 — CAT. 8 DENTAL DEVICES (April 5, 1984)
  • K834171 — OP-CON SURG. INSTRUMENT #3 (April 4, 1984)
  • K834191 — JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (March 22, 1984)
  • K834192 — JAKOBI SURG. INSTRUMENTS #3 21/22/24 (March 22, 1984)

Other clearances for product code HTD

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  • K974595 — CUSHING BAYONET, INSULATED BIPOLAR FORCEP (June 24, 1998)
  • K974594 — SEMKIN BIPOLAR FORCEP (June 24, 1998)
  • K974593 — SEMKIN INSULATED BIPOLAR FORCEP (June 24, 1998)
  • K913964 — MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS (October 23, 1991)
  • K911180 — CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS (March 29, 1991)
  • K895212 — TIK EXTRAKTOR (September 27, 1989)
  • K890373 — HEMORRHOIDAL FORCEPS (February 3, 1989)
  • K890369 — GALL STONE FORCEPS (February 3, 1989)
  • K890258 — BONE CUTTING FORCEPS, SINGLE-ACTION (January 27, 1989)