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510(k) K940275

UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD by P.J. Products, Inc. — Product Code HOY

K940275 is an FDA 510(k) premarket notification submitted by P.J. Products, Inc. for the device "UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD". The FDA issued a decision of Substantially Equivalent on Mar 24, 1994. The device falls under product code HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)), a Class I device regulated under 21 CFR 886.4750. P.J. Products, Inc. has 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 24, 1994
Date Received
Jan 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Device Class
Class I
Regulation Number
886.4750
Review Panel
OP
Submission Type
510(k) Exempt

Other clearances by P.J. Products, Inc.

  • K940213 — UNIVERSAL CUSHIONED METAL EYE SHIELD (Mar 24, 1994)
  • K940095 — FOX EYE ALUMINUM SHIELD, OPHTHALMIC (Mar 1, 1994)

Other clearances for product code HOY

  • K132042 — AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND (Apr 28, 2014)
  • K050856 — LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM (May 31, 2005)
  • K971465 — NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS (Jun 4, 1997)
  • K944700 — ARCTIC PREMIER SERIES (Dec 22, 1994)
  • K944857 — GOGGLE SAFEGUARD (Dec 15, 1994)
  • K945351 — SHIELD, EYE, OPHTHALMIC (Dec 13, 1994)
  • K945346 — MAKROLON 2405 GOGGLES (LIGHT AND DARK) (Nov 22, 1994)
  • K942407 — AMCON SLIP IN MYDRIATIC SUNGLASSES (Jun 6, 1994)
  • K941829 — SUN FILTERS/SHIELDS (May 17, 1994)
  • K930347 — SHAIDS PROTECTIVE GLASSES (Apr 29, 1994)

FDA data resources