The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Percuguide Lesion Marking.
| Device ID | K920816 |
| 510k Number | K920816 |
| Device Name: | PERCUGUIDE LESION MARKING |
| Classification | Guide, Needle, Surgical |
| Applicant | E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls, NY 12801 |
| Contact | Marlene Wright |
| Correspondent | Marlene Wright E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls, NY 12801 |
| Product Code | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-06 |
| Decision Date | 1992-04-21 |