510(k) K820301
K820301 is an FDA 510(k) premarket notification submitted by North American Biologicals, Inc. for the device "PLASMA POOLER HEAT SEALER". The FDA issued a decision of Substantially Equivalent on April 9, 1982. The device falls under product code KSD (Device, Heat-Sealing), a Class I device regulated under 21 CFR 864.9750. North American Biologicals, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1982
- Date Received
- February 4, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Heat-Sealing
- Device Class
- Class I
- Regulation Number
- 864.9750
- Review Panel
- HE
- Submission Type