NITROGLYCERINE CONTAINER
FDA 510(k) clearance K833311 · decided 1984-02-04
Clearance details
- K-number
- K833311
- Device name
- NITROGLYCERINE CONTAINER
- Applicant
- Apothecary Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-26
- Decision date
- 1984-02-04
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- NXB
- Device class
- 1
- Regulation number
- 890.5050
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Burnsville, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THE HEART PROTECTOR (K944481) | Garan Scientific, Inc. | 1995-04-10 |
| TAB PAK (K882731) | Dynex Trading Co. | 1988-12-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THE NORMALINE KIT (P800055/S002) | Apothecary Products, Inc. | 1983-05-27 |
| THE NORMALINE KIT (P800055/S001) | Apothecary Products, Inc. | 1982-02-05 |