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510(k) K802818

PULLEN POCKET SCOPE by P.A. Research Corp. — Product Code IBJ

K802818 is an FDA 510(k) premarket notification submitted by P.A. Research Corp. for the device "PULLEN POCKET SCOPE". The FDA issued a decision of Substantially Equivalent on April 17, 1981. The device falls under product code IBJ (Light, Microscope), a Class I device regulated under 21 CFR 864.3600. P.A. Research Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1981
Date Received
November 7, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Microscope
Device Class
Class I
Regulation Number
864.3600
Review Panel
PA
Submission Type

Other clearances by P.A. Research Corp.

  • K892771 — PATIENT EXAMINATION GLOVES (POLY) (September 13, 1989)

Other clearances for product code IBJ

  • K874750 — VIDEO ANALYZER 4000 (April 25, 1988)
  • K874190 — CELL COUNTING GRID GRATICULE (January 5, 1988)
  • K874207 — THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION (January 5, 1988)
  • K864049 — MCARTHUR MICROSCOPE, STANDARD METAL VERSION (October 29, 1986)
  • K854735 — MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. (December 10, 1985)
  • K823040 — PATHOLOGY INSTRUMENTATION & ACCESSORIES (January 14, 1983)
  • K822207 — 2XC MICROSCOPE (August 5, 1982)
  • K821865 — A O MICROSCOPE VIDEO SYSTEM (July 14, 1982)

FDA data resources