The following data is part of a premarket notification filed by North American Biologicals, Inc. with the FDA for Plasma Pooler Heat Sealer.
| Device ID | K820301 |
| 510k Number | K820301 |
| Device Name: | PLASMA POOLER HEAT SEALER |
| Classification | Device, Heat-sealing |
| Applicant | NORTH AMERICAN BIOLOGICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KSD |
| CFR Regulation Number | 864.9750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-04 |
| Decision Date | 1982-04-09 |