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510(k) K873918

HEAD & CHIN RESTS by Richmond Products, Inc. — Product Code HRH

K873918 is an FDA 510(k) premarket notification submitted by Richmond Products, Inc. for the device "HEAD & CHIN RESTS". The FDA issued a decision of Substantially Equivalent on October 28, 1987. The device falls under product code HRH (Trephine, Manual, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Richmond Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1987
Date Received
September 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trephine, Manual, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Richmond Products, Inc.

  • K874252 — KREDA DISC (January 27, 1988)
  • K874251 — WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT (January 11, 1988)
  • K874250 — THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT. (January 11, 1988)
  • K873907 — CONFIRMATION TESTS (December 29, 1987)
  • K873908 — H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. (December 23, 1987)
  • K873914 — ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) (December 11, 1987)
  • K873916 — 'E' CUBE AND 'E' PAD (December 11, 1987)
  • K873911 — PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 (December 2, 1987)
  • K873913 — COLOR BOOK ILLUMINATOR STAND (December 2, 1987)
  • K873917 — TONOMETER TAPES (November 2, 1987)

Other clearances for product code HRH

  • K022843 — GAYHEART CORNEAL EXCISION DEVICE (November 1, 2002)
  • K931792 — ARTHROSCOPE (June 13, 1994)
  • K864520 — BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON (January 20, 1987)
  • K862524 — DEKNATEL (R) TREPHINE (August 11, 1986)
  • K861825 — CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE (June 9, 1986)
  • K860648 — BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA (March 25, 1986)
  • K843646 — STEINWAY MICRO-KERATO-TREPHINE (January 3, 1985)
  • K843048 — RING SUPPORTED TREPHINE FOR CORNEA TRANS (October 5, 1984)
  • K812723 — PEARCE CORNEAL TREPHINE (October 13, 1981)
  • K781411 — CORNEAL CUTTER AND ACCESSORIES (September 20, 1978)

FDA data resources