IM COLLAGEN SHIELD
FDA 510(k) clearance K896449 · decided 1990-05-24
Clearance details
- K-number
- K896449
- Device name
- IM COLLAGEN SHIELD
- Applicant
- Intermedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-11-09
- Decision date
- 1990-05-24
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- MOE
- Device class
- 1
- Regulation number
- 886.4750
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Safety Harbor, FL, 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 |
|---|---|---|
| BIO-COR COLLAGEN CORNEAL SHIELD (K944872) | Bausch & Lomb Healthcare and Optics Worldwide | 1995-07-26 |
| MEDILENS-CS CORNEAL SHIELD (K915861) | Chiron Ophthalmics | 1992-03-06 |
| SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS (K914529) | Oasis Medical, Inc. | 1991-11-13 |
| COLLAGEN SHIELD FOR ACUTE CARE (K913148) | Vitaphore Corp. | 1991-10-15 |
| COLLAGEN SHIELD, VARIOUS MODELS (K905825) | Chiron Ophthalmics | 1991-06-10 |
| COLLAGEN SHIELD FOR ACUTE CARE (K902558) | Vitaphore Corp. | 1990-08-17 |
| MEDILENS(TM) CORNEAL SHIELD (K901880) | Chiron Ophthalmics | 1990-07-02 |
| ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA (K884962) | Bausch & Lomb Pharmaceutical, Inc. | 1990-02-09 |
| COI 72 HR COLLAGEN SHIELD (K885015) | Chiron Ophthalmics | 1989-06-23 |
| ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL (K884960) | Bausch & Lomb Pharmaceutical, Inc. | 1989-02-13 |
| ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL (K884961) | Bausch & Lomb Pharmaceutical, Inc. | 1989-02-13 |
| COI 24 HR COLLAGEN SHIELD (K885016) | Chiron Ophthalmics | 1989-02-01 |
Recalls involving this device
No recalls on record reference this clearance.