APPLIED LABORATORIES STERILE SALINE SOLUTION
FDA premarket approval P870002/S001 · decided 1988-05-25
Approval details
- PMA number
- P870002
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- APPLIED LABORATORIES STERILE SALINE SOLUTION
- Generic name
- Accessories, soft lens products
- Applicant
- Applied Laboratories, Inc.
- Date received
- 1988-01-27
- Decision date
- 1988-05-25
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Columbus, IN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000 (K873824) | Applied Laboratories, Inc. | 1988-03-24 |
| MOBAY (BAYER) MAKROLON 2658 3291 (K873823) | Applied Laboratories, Inc. | 1988-03-24 |
| MOBAY (BAYER) MAKROLON 2658 1112 (K873820) | Applied Laboratories, Inc. | 1988-03-24 |
| GE LEXAN 144R 112 (K873825) | Applied Laboratories, Inc. | 1988-03-24 |
| GE NORYL 731-80089S (K873821) | Applied Laboratories, Inc. | 1988-03-24 |
| MOBAY (BAYER) MERLON M-40 (H)F 1112 (K873822) | Applied Laboratories, Inc. | 1988-03-24 |
| KESTREL CONTACT LENS CASE (K871714) | Applied Laboratories, Inc. | 1987-05-26 |
| EASY EYES TM LENS CARRYING CASE (K860677) | Applied Laboratories, Inc. | 1986-05-29 |