510(k) K943010
K943010 is an FDA 510(k) premarket notification submitted by Mission Pharmacal Co. for the device "MAXILUBE". The FDA issued a decision of Substantially Equivalent on Jul 19, 1995. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Mission Pharmacal Co. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 19, 1995
- Date Received
- Jun 24, 1994
- 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