510(k) K843491
K843491 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "CONCEPT FIBER OPTIC CANALICULUS INTUBA". The FDA issued a decision of Substantially Equivalent on Oct 5, 1984. The device falls under product code HNL (Probe, Lachrymal), a Class I device regulated under 21 CFR 886.4350. Concept, Inc. has 82 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 5, 1984
- Date Received
- Sep 6, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Probe, Lachrymal
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type
- 510(k) Exempt