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510(k) K871474

PART #860070 ULTRAPAK & #860075 ULTRAPAK by Medical Technical Products — Product Code HOC

K871474 is an FDA 510(k) premarket notification submitted by Medical Technical Products for the device "PART #860070 ULTRAPAK & #860075 ULTRAPAK". The FDA issued a decision of Substantially Equivalent on August 10, 1987. The device falls under product code HOC (Clip, Iris Retractor), a Class I device regulated under 21 CFR 886.4350. Medical Technical Products has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1987
Date Received
April 14, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Iris Retractor
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Medical Technical Products

  • K940083 — STANDARD PHACO TIP 15, 30, 45, 60 (September 28, 1994)
  • K940088 — MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE (August 4, 1994)
  • K940084 — MODEL 2000 OPHTHALMIC SURGICAL SYSTEM (June 17, 1994)
  • K910335 — MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA (March 13, 1991)
  • K905251 — MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A (February 7, 1991)
  • K904612 — I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM) (December 26, 1990)
  • K871473 — PART #860065 IA PAK & PART #860060 IA PAK (August 10, 1987)

Other clearances for product code HOC

  • K830871 — PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION (June 2, 1983)

FDA data resources