The following data is part of a premarket notification filed by Dale Medical Products, Inc. with the FDA for Dale(r) Nasal Dressing Holder (product No. 600).
| Device ID | K914245 |
| 510k Number | K914245 |
| Device Name: | DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) |
| Classification | Tape And Bandage, Adhesive |
| Applicant | DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Contact | Egidia M Vergano |
| Correspondent | Egidia M Vergano DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-23 |
| Decision Date | 1991-12-09 |