THE NORMALINE KIT
FDA premarket approval P800055/S002 · decided 1983-05-27
Approval details
- PMA number
- P800055
- Supplement
- S002
- Trade name
- THE NORMALINE KIT
- Generic name
- Accessories, soft lens products
- Applicant
- Apothecary Products, Inc.
- Date received
- 1982-09-15
- Decision date
- 1983-05-27
- Days to decision
- 254 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Burnsville, MN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FLENTS PLASTIC EYE WASH CUP (K140409) | Apothecary Products, Inc. | 2014-07-09 |
| SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE (K111856) | Apothecary Products, Inc. | 2011-07-14 |
| EZY-TRAVEL WRISTBAND (K041766) | Apothecary Products, Inc. | 2004-11-26 |
| ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 (K020296) | Apothecary Products, Inc. | 2002-06-25 |
| PATIENT EXAMINATION GLOVES (LATEX) (K892242) | Apothecary Products, Inc. | 1989-05-12 |
| NITROGLYCERINE CONTAINER (K833311) | Apothecary Products, Inc. | 1984-02-04 |