510(k) K973557
K973557 is an FDA 510(k) premarket notification submitted by Qualis, Inc. for the device "LUBRIGLIDE". The FDA issued a decision of Substantially Equivalent on October 10, 1997. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Qualis, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1997
- Date Received
- September 19, 1997
- 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