510(k) K861877
K861877 is an FDA 510(k) premarket notification submitted by Byron Medical for the device "BYRON WORD BARTHOLIAN GLAND CATHETER". The FDA issued a decision of Substantially Equivalent on May 30, 1986. The device falls under product code GBA (Catheter, Balloon Type), a Class I device regulated under 21 CFR 878.4200. Byron Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 1986
- Date Received
- May 15, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Balloon Type
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type