510(k) K971067
K971067 is an FDA 510(k) premarket notification submitted by Medical Instrument Development Laboratories, Inc. for the device "DIGI-INJECTOR". The FDA issued a decision of Substantially Equivalent on September 19, 1997. The device falls under product code MRH (Pump, Infusion, Ophthalmic), a Class II device regulated under 21 CFR 880.5725. Medical Instrument Development Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 1997
- Date Received
- March 24, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- OP
- Submission Type