510(k) K862070
K862070 is an FDA 510(k) premarket notification submitted by Intermedics Intraocular, Inc. for the device "INTER-SHARP". The FDA issued a decision of Substantially Equivalent on June 17, 1986. The device falls under product code HNW (Dilator, Lachrymal), a Class I device regulated under 21 CFR 886.4350. Intermedics Intraocular, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1986
- Date Received
- May 30, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Lachrymal
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type