The following data is part of a premarket notification filed by Graham-field, Inc. with the FDA for Medicopaste Bandage With Calamine/modification.
| Device ID | K904904 |
| 510k Number | K904904 |
| Device Name: | MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION |
| Classification | Tape And Bandage, Adhesive |
| Applicant | GRAHAM-FIELD, INC. 400 RABRO DR. EAST Hauppauge, NY 11788 |
| Contact | Maria Simat |
| Correspondent | Maria Simat GRAHAM-FIELD, INC. 400 RABRO DR. EAST Hauppauge, NY 11788 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-30 |
| Decision Date | 1991-03-19 |