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FDA 510(k), K003867, EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
FDA 510(k), K003867, EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
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510(K) Number: K003867
Device Name: EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
Manufacturer: ROBERT L DE ARMOND
Device Classification Name: Lubricant, Personal
Regulation Number: NUC
Classification Product Code: 12/12/2000
Date Received: 03/09/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
Manufacturer: ROBERT L DE ARMOND
Device Classification Name: Lubricant, Personal
Regulation Number: NUC
Classification Product Code: 12/12/2000
Date Received: 03/09/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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