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510(k) K884360

SEIKO P-6 PROGRESSIVE SPECTACLE LENSES by Seiko Corp. — Product Code HQG

K884360 is an FDA 510(k) premarket notification submitted by Seiko Corp. for the device "SEIKO P-6 PROGRESSIVE SPECTACLE LENSES". The FDA issued a decision of Substantially Equivalent on November 15, 1988. The device falls under product code HQG (Lens, Spectacle, Non-Custom (Prescription)), a Class I device regulated under 21 CFR 886.5844. Seiko Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1988
Date Received
October 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Spectacle, Non-Custom (Prescription)
Device Class
Class I
Regulation Number
886.5844
Review Panel
OP
Submission Type

Other clearances by Seiko Corp.

  • K900732 — SPECTACLE FRAME (June 20, 1990)

Other clearances for product code HQG

  • K935919 — SUNGLASSES (February 16, 1994)
  • K920795 — 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX (July 13, 1992)
  • K900091 — MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR (April 4, 1990)
  • K882814 — NEOLENS PRESCRIPTION SPECTACLE LENS (July 29, 1988)
  • K882308 — CR-39 PLASTIC LENSES FOR EYEGLASSES (July 22, 1988)
  • K881225 — OPHTHALMIC SPECTACLE LENS BLANKS (April 19, 1988)
  • K875063 — SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. (February 22, 1988)
  • K874681 — SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES (February 5, 1988)
  • K873245 — AR DIACOAT SINGLE VISION LENSES (October 5, 1987)
  • K872506 — MELANITE I (July 27, 1987)

FDA data resources