510(k) K950633
K950633 is an FDA 510(k) premarket notification submitted by Candela Laser Corp. for the device "CANDELA URETHRAL/BLADDER SOUND". The FDA issued a decision of Substantially Equivalent on March 6, 1995. The device falls under product code FBX (Sound, Urethral, Metal Or Plastic), a Class I device regulated under 21 CFR 876.5520. Candela Laser Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 1995
- Date Received
- February 13, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sound, Urethral, Metal Or Plastic
- Device Class
- Class I
- Regulation Number
- 876.5520
- Review Panel
- GU
- Submission Type