510(k) K982421
K982421 is an FDA 510(k) premarket notification submitted by International Isotopes, Inc. for the device "IMAGYN 125 I SEED, MODEL IS 125". The FDA issued a decision of Substantially Equivalent on July 31, 1998. The device falls under product code IWG (Seed, Isotope, Gold, Titanium, Platinum), a Class II device regulated under 21 CFR 892.5730. International Isotopes, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1998
- Date Received
- July 13, 1998
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Seed, Isotope, Gold, Titanium, Platinum
- Device Class
- Class II
- Regulation Number
- 892.5730
- Review Panel
- RA
- Submission Type