FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HOOD NASAL SPLINT
K Number: K890599
·
Decision Mar 17, 1989
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
14
Applicant Total
19
Review Days
39
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HOOD NASAL SPLINT
- K Number
- K890599
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5800
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Hood Laboratories
- Date Received
- February 6, 1989
- Decision Date
- March 17, 1989
- Product Code
- EPP
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EPP | Splint, Nasal | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EPP), ordered by most recent decision date.
AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
EXTERNAL NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
AMERICAN NASAL SPONGE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
'EXMOOR' ATKINS NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Hood Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K921452 | ACOUSTIC RHINOMETER | Jul 8, 1993 | Substantially Equivalent |
| K920994 | HOOD NASAL SEPTAL BUTTON | May 15, 1992 | Substantially Equivalent |
| K905703 | KRUPIN EYE VALVE WITH DISK | Mar 15, 1991 | Substantially Equivalent |
| K904821 | ELIACHAR MODIFIED ESOPHAGEAL STENT | Jan 14, 1991 | Substantially Equivalent |
| K897049 | GIBSON ENDOLYMPHATIC SHUNT | Mar 16, 1990 | Substantially Equivalent |
| K897059 | HOOD SPEAKING VALVE | Mar 12, 1990 | Substantially Equivalent |
| K893866 | HOOD PEDIATRIC TRACHEOSTOMY TUBE | Aug 7, 1989 | Substantially Equivalent |
| K884810 | SILICONE LARYNGEAL STENT | May 10, 1989 | Substantially Equivalent |
| K885125 | KRUPIN EYE VALVE W/SCLERAL BUCKLE | Jan 24, 1989 | Substantially Equivalent |
| K882430 | HOOD TRACHEAL STOMA BUTTON | Jun 28, 1988 | Substantially Equivalent |