510(k) K792383
K792383 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "KELMAN DIPSTICK". The FDA issued a decision of Substantially Equivalent on December 11, 1979. The device falls under product code HOE (Caliper, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. V. Mueller O.V. Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1979
- Date Received
- November 26, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Caliper, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type