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510(k) K853129

BEAVER MULTIPURPOSE SAPPHIRE KNIFE by Rudolph Beaver, Inc. — Product Code HNN

K853129 is an FDA 510(k) premarket notification submitted by Rudolph Beaver, Inc. for the device "BEAVER MULTIPURPOSE SAPPHIRE KNIFE". The FDA issued a decision of Substantially Equivalent on August 6, 1985. The device falls under product code HNN (Knife, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Rudolph Beaver, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1985
Date Received
July 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Rudolph Beaver, Inc.

  • K883361 — ARTHRO-TRAC(TM) (October 13, 1988)
  • K875030 — OCU-1 (May 3, 1988)
  • K862709 — MECHANICAL CYSTITOME (August 1, 1986)
  • K860305 — BEAVER MICRO-GEM GAUGE BLOCK (February 12, 1986)
  • K852828 — BEAVER R-K KNIFE (November 4, 1985)

Other clearances for product code HNN

  • K110166 — CLEARCUT S SAFETY KNIFE (May 20, 2011)
  • K922378 — OPHTHALMIC KNIFE (December 10, 1992)
  • K882402 — RETRACTIVE INCISION MICROMETER (RIM) GUAGE (August 22, 1988)
  • K881669 — MVR/STILETTO BLADE 20GA. - P/N 1900 (May 13, 1988)
  • K874979 — PRISMA DISPOSABLE MVR/STILETTO BLADE (April 13, 1988)
  • K874057 — OPHTHALMIC TIP & BLADE SCALPELS (December 23, 1987)
  • K874056 — OPHTHALMIC DISPOSABLE BLADES (December 22, 1987)
  • K873385 — OPHTHALMIC PHACO-BLADE (September 21, 1987)
  • K871285 — KNIFE, OPHTHALMIC (April 27, 1987)
  • K864290 — RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE (December 15, 1986)

FDA data resources