510(k) K103718
K103718 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "DYNACOR LUBRICATION GEL". The FDA issued a decision of Substantially Equivalent on May 10, 2011. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2011
- Date Received
- December 21, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lubricant, Patient
- Device Class
- Class I
- Regulation Number
- 880.6375
- Review Panel
- HO
- Submission Type