510(k) K881363
K881363 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "SYRINGE PREFILLED WITH WATER". The FDA issued a decision of Substantially Equivalent on June 23, 1988. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. I M, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1988
- Date Received
- March 31, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urological
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type