K914245 is an FDA 510(k) clearance for the DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600). This device is classified as a Tape And Bandage, Adhesive (Class I - General Controls, product code KGX).
Submitted by Dale Medical Products, Inc. (Plainville, US). The FDA issued a Cleared decision on December 9, 1991, 77 days after receiving the submission on September 23, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K914245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1991 |
| Decision Date | December 09, 1991 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5240 |