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510(k) K200731

pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 by Pjur Group Luxembourg S.A. — Product Code NUC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2021
Date Received
March 20, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

Other clearances by Pjur Group Luxembourg S.A.

  • K260068 — pjur NATURE Touch, 100 ml (May 21, 2026)
  • K200527 — pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur (February 19, 2021)
  • K200730 — pjur WOMAN Nude pjur med SENSITIVE glide (December 17, 2020)
  • K141913 — PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME! (April 6, 2015)
  • K133336 — PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PR (July 24, 2014)
  • K133233 — PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE (July 18, 2014)

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