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510(k) K902308

TAMCENAN OCULAR EXPLANTS AND BANDS by Tamcenan Corp. — Product Code HQX

K902308 is an FDA 510(k) premarket notification submitted by Tamcenan Corp. for the device "TAMCENAN OCULAR EXPLANTS AND BANDS". The FDA issued a decision of Substantially Equivalent on June 19, 1990. The device falls under product code HQX (Implant, Orbital, Extra-Ocular), a Class II device regulated under 21 CFR 886.3340. Tamcenan Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1990
Date Received
May 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Orbital, Extra-Ocular
Device Class
Class II
Regulation Number
886.3340
Review Panel
OP
Submission Type

Other clearances by Tamcenan Corp.

  • K905750 — LACRIMAL PLUG (March 14, 1991)
  • K901618 — OCULAR INFUSION CANNULA SYSTEM (May 31, 1990)

Other clearances for product code HQX

  • K023481 — MICROVISION SCLERAL BUCKLING COMPONENTS (January 8, 2003)
  • K983581 — OCU-GUARD AND OCU-GUARD SUPPLE (November 6, 1998)
  • K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (September 18, 1998)
  • K963219 — RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND S (October 28, 1996)
  • K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS (June 5, 1996)
  • K950599 — STORS SCLERAL SPONGE II (LINCOFF DESIGN) (March 2, 1995)
  • K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (January 17, 1995)
  • K901002 — O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES (May 22, 1990)
  • K900929 — PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL (May 18, 1990)
  • K900928 — COX MALAR EMINENCE IMPLANTS (May 15, 1990)

FDA data resources