510(k) K940632
K940632 is an FDA 510(k) premarket notification submitted by Medi-Physics Inc. Dba Nycomed Amersham Imaging for the device "I-125 RAPID STRAND". The FDA issued a decision of Substantially Equivalent on September 2, 1994. The device falls under product code IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum), a Class II device regulated under 21 CFR 892.5730. Medi-Physics Inc. Dba Nycomed Amersham Imaging has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 1994
- Date Received
- February 14, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source, Isotope, Sealed, Gold, Titanium, Platinum
- Device Class
- Class II
- Regulation Number
- 892.5730
- Review Panel
- RA
- Submission Type