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510(k) K780987

SOFT SILICONE ELASTOMER SPONGE EXPLANT by Medical Instrument Research Assoc., Inc. — Product Code HOZ

K780987 is an FDA 510(k) premarket notification submitted by Medical Instrument Research Assoc., Inc. for the device "SOFT SILICONE ELASTOMER SPONGE EXPLANT". The FDA issued a decision of Substantially Equivalent on September 28, 1978. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. Medical Instrument Research Assoc., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1978
Date Received
June 14, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sponge, Ophthalmic
Device Class
Class II
Regulation Number
886.4790
Review Panel
OP
Submission Type

Other clearances by Medical Instrument Research Assoc., Inc.

  • K791510 — BLUE FIELD ENTOPTOSCOPE BFE100 (December 11, 1979)
  • K770888 — POMERANTZEFF EQUATOR PLUS CAMERA (June 3, 1977)
  • K760550 — IMPLANT, SILICONE AND TANTALUM (October 5, 1976)

Other clearances for product code HOZ

  • K132796 — SUNTOUCH EYE SPEAR (October 30, 2013)
  • K130117 — NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS (October 29, 2013)
  • K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (October 23, 2009)
  • K082460 — CENEFOM PVA SURGICAL SPEAR (December 15, 2008)
  • K012196 — ULTRACELL ABSORBENT STICK (August 24, 2001)
  • K011191 — MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES (June 26, 2001)
  • K003842 — PRESCOTT'S SURGICAL SPEAR (April 13, 2001)
  • K002279 — ML EYE SPEAR, MODEL ML 27 ES (August 18, 2000)
  • K993883 — M-PACT CORNEAL LIGHT SHIELD (December 21, 1999)
  • K990671 — DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIP (May 10, 1999)

FDA data resources