510(k) K832138
K832138 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "BIOMER * PLEDGET SUTURE BUTTRESS". The FDA issued a decision of Substantially Equivalent on May 23, 1984. The device falls under product code KGS (Retention Device, Suture), a Class I device regulated under 21 CFR 878.4930. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1984
- Date Received
- July 1, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retention Device, Suture
- Device Class
- Class I
- Regulation Number
- 878.4930
- Review Panel
- SU
- Submission Type