510(k) K833857
K833857 is an FDA 510(k) premarket notification submitted by Polymer Technology Corp. for the device "MACLEAN-FOGG, TISSUE CASSETTES". The FDA issued a decision of Substantially Equivalent on December 2, 1983. The device falls under product code IDZ (Cassettes, Tissue), a Class I device regulated under 21 CFR 864.3010. Polymer Technology Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1983
- Date Received
- November 7, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cassettes, Tissue
- Device Class
- Class I
- Regulation Number
- 864.3010
- Review Panel
- PA
- Submission Type