The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Vacushield Tm.
| Device ID | K813159 |
| 510k Number | K813159 |
| Device Name: | VACUSHIELD TM |
| Classification | Unit, Filter, Membrane |
| Applicant | GELMAN SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JRL |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-16 |
| Decision Date | 1981-12-08 |