510(k) K870978
K870978 is an FDA 510(k) premarket notification submitted by Sur-Med Instruments, Inc. for the device "T-TUBE INSERTER". The FDA issued a decision of Substantially Equivalent on March 19, 1987. The device falls under product code JYM (Inserter, Myringotomy Tube), a Class I device regulated under 21 CFR 874.4420. Sur-Med Instruments, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1987
- Date Received
- March 10, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Inserter, Myringotomy Tube
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type