ORCOLON (R) (POLYACRYLAMIDE)
FDA premarket approval P900010/S001 · decided 1991-07-03
Approval details
- PMA number
- P900010
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ORCOLON (R) (POLYACRYLAMIDE)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Optical Radiation Corp.
- Date received
- 1991-05-14
- Decision date
- 1991-07-03
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Azusa, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX (K920795) | Optical Radiation Corp. | 1992-07-13 |
| COMPUTON(R) (K863200) | Optical Radiation Corp. | 1986-09-03 |
| ORC ORACLE (K853668) | Optical Radiation Corp. | 1985-10-15 |