← Product Code [KSD](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSD) · K820301

# PLASMA POOLER HEAT SEALER (K820301)

_North American Biologicals, Inc. · KSD · Apr 9, 1982 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSD/K820301

## Device Facts

- **Applicant:** North American Biologicals, Inc.
- **Product Code:** [KSD](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSD.md)
- **Decision Date:** Apr 9, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.9750
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSD/K820301](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSD/K820301)

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