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FDA 510(k), K101522, ULTRA SEAL STERILE LUBRICATING JELLY
FDA 510(k), K101522, ULTRA SEAL STERILE LUBRICATING JELLY
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510(K) Number: K101522
Device Name: ULTRA SEAL STERILE LUBRICATING JELLY
Manufacturer: ULTRA SEAL CORPORATION
Device Classification Name: lubricant, patient
Regulation Number: 880.6375
Classification Product Code: KMJ
Date Received: 06/02/2010
Decision Date: 12/23/2010
Regulation Medical Specialty: General Hospital
Device Name: ULTRA SEAL STERILE LUBRICATING JELLY
Manufacturer: ULTRA SEAL CORPORATION
Device Classification Name: lubricant, patient
Regulation Number: 880.6375
Classification Product Code: KMJ
Date Received: 06/02/2010
Decision Date: 12/23/2010
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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