FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)
K Number: K914245
·
Decision Dec 9, 1991
Classifications
1
FEI Numbers
934
Registration Numbers
934
Same Product Code
183
Applicant Total
13
Review Days
77
Basic Information
- Device Name
- DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)
- K Number
- K914245
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DALE MEDICAL PRODUCTS, INC.
- Date Received
- September 23, 1991
- Decision Date
- December 9, 1991
- Product Code
- KGX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.
SERAGARD INJECTION PATCH
FDA 510(k)
FDA Class 1
·General Hospital
CARE BAND ANTIBACTERIAL BANDAGES
FDA 510(k)
FDA Class 1
·General Hospital
SYVEK PATCH
FDA 510(k)
FDA Class 1
·General Hospital
ADHESIVE BANDAGES WITH OTC DRUG
FDA 510(k)
FDA Class 1
·General Hospital
TARGETT PATCH
FDA 510(k)
FDA Class 1
·General Hospital
PARALLEL
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by DALE MEDICAL PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K082241 | THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 | Oct 30, 2008 | Substantially Equivalent |
| K994300 | NASOGASTRIC TUBE HOLDER, MODEL 160 | Feb 10, 2000 | Substantially Equivalent |
| K964399 | DALE ENDOTRACHEAL TUBE HOLDER 270/280 | Jan 28, 1997 | Substantially Equivalent |
| K961693 | DALE GASTROSTOMY TUBE HOLDER | Jul 30, 1996 | Substantially Equivalent |
| K951491 | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS | Apr 24, 1995 | Substantially Equivalent |
| K905231 | DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. | Jan 14, 1991 | Substantially Equivalent |
| K894586 | DALE I.V. IDENTIFIER; PRODUCT #1125 | Aug 15, 1989 | Substantially Equivalent |
| K873311 | DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 | Nov 5, 1987 | Substantially Equivalent |
| K864897 | DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 | Jan 12, 1987 | Substantially Equivalent |
| K860583 | DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 | Feb 21, 1986 | Substantially Equivalent |