The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Percu Guide I (loop Type).
| Device ID | K863090 |
| 510k Number | K863090 |
| Device Name: | PERCU GUIDE I (LOOP TYPE) |
| Classification | Guide, Needle, Surgical |
| 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 | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-13 |
| Decision Date | 1986-08-29 |