510(k) K820521
K820521 is an FDA 510(k) premarket notification submitted by General Medical Co. for the device "STERILIZATION WRAP". The FDA issued a decision of Substantially Equivalent on March 18, 1982. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. General Medical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 1982
- Date Received
- February 26, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wrap, Sterilization
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type