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510(k) K903001

SLIMCATH (TM) by Gynopharma, Inc. — Product Code HIT

K903001 is an FDA 510(k) premarket notification submitted by Gynopharma, Inc. for the device "SLIMCATH (TM)". The FDA issued a decision of Substantially Equivalent on June 25, 1991. The device falls under product code HIT (Tester, Color Vision), a Class I device regulated under 21 CFR 886.1170. Gynopharma, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1991
Date Received
July 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Color Vision
Device Class
Class I
Regulation Number
886.1170
Review Panel
OP
Submission Type

Other clearances by Gynopharma, Inc.

  • K903002 — PROBET (TM) (April 5, 1991)

Other clearances for product code HIT

  • K875026 — ANOMALOSCOPE PLATE TEST - 5 [APT-5] (February 5, 1988)
  • K873908 — H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. (December 23, 1987)
  • K873911 — PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 (December 2, 1987)
  • K844694 — TITMUS VISION TESTER II (January 22, 1985)
  • K844365 — COLOR VISION TESTERS (January 2, 1985)
  • K832843 — OSCAR COLOUR VISION TESTER (January 4, 1984)
  • K831074 — OSCAR COLOR VISION TESTER (April 28, 1983)
  • K810700 — CHROMOPS FM-100 COLOR VISION TESTER (April 10, 1981)

FDA data resources