The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for E-z-guard Mouthpiece.
| Device ID | K853402 |
| 510k Number | K853402 |
| Device Name: | E-Z-GUARD MOUTHPIECE |
| Classification | Mouthpiece, Breathing |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Jack T Berger |
| Correspondent | Jack T Berger E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | BYP |
| CFR Regulation Number | 868.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-10-23 |