The following data is part of a premarket notification filed by American Scientific Products with the FDA for Vaspar Sealent.
| Device ID | K812191 |
| 510k Number | K812191 |
| Device Name: | VASPAR SEALENT |
| Classification | Formulations, Paraffin, All |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KEO |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-03 |
| Decision Date | 1981-08-31 |