FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEONATE MASK FOR BABIES
K Number: K840444
·
Decision Mar 16, 1984
Classifications
1
FEI Numbers
769
Registration Numbers
769
Same Product Code
54
Applicant Total
71
Review Days
44
Basic Information
- Device Name
- NEONATE MASK FOR BABIES
- K Number
- K840444
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- RICHARDS MEDICAL CO., INC.
- Date Received
- February 1, 1984
- Decision Date
- March 16, 1984
- Product Code
- HOY
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | FDA class 1 | Ophthalmic |
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Other Clearances by RICHARDS MEDICAL CO., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K896106 | ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS | Jun 25, 1990 | Substantially Equivalent for Some Indications |
| K900628 | MODULAR HIP SYSTEM | May 9, 1990 | Substantially Equivalent for Some Indications |
| K896580 | UNI-POLAR HEAD | Feb 15, 1990 | Substantially Equivalent |
| K895241 | INTRAMEDULLARY HIP SCREW | Jan 4, 1990 | Substantially Equivalent |
| K884824 | TRICON-M TOTAL KNEE SYSTEM | Nov 21, 1989 | Substantially Equivalent for Some Indications |
| K896204 | ZIRCONIA CERAMIC HEAD ADD'L SIZES | Nov 20, 1989 | Substantially Equivalent for Some Indications |
| K895242 | PAPPAS TRI-FLANGE VENTILATION TUBE | Nov 17, 1989 | Substantially Equivalent |
| K893377 | RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS | Nov 16, 1989 | Substantially Equivalent |
| K885069 | ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) | Sep 1, 1989 | Substantially Equivalent for Some Indications |
| K890132 | POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP. | Jul 19, 1989 | Substantially Equivalent for Some Indications |