510(k) K853132
K853132 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "EMERSON TRO/CATH TROCAR CATHETERS". The FDA issued a decision of Substantially Equivalent on January 8, 1986. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. J. H. Emerson Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 1986
- Date Received
- July 26, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trocar
- Device Class
- Class II
- Regulation Number
- 870.1390
- Review Panel
- CV
- Submission Type