510(k) K880991
K880991 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "LASER OPTICAL CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on May 25, 1988. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 1988
- Date Received
- March 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Surgical, Gynecologic
- Device Class
- Class II
- Regulation Number
- 884.4550
- Review Panel
- OB
- Submission Type