510(k) K896449
- Device
- IM COLLAGEN SHIELD
- Applicant
- INTERMEDICAL, INC.
- 510(k) number
- K896449
- Product code
- MOE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-05-24
- Date received
- 1989-11-09
- Regulation
- 886.4750
- Classification name
- Collagen Corneal Shield
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RON THERIOT
- Address
- 1101 Knollwood Dr. Safety Harbor FL US 34695 34695
FDA Registration Numbers#
- 1720747
- 3006234743
- 8043542
- 1836161
- 1920664
- 1610287
- 2083373
- 1226074
- 1313525
- 2024024
- 3003039352
- 8030607
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MOE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944872 | BIO-COR COLLAGEN CORNEAL SHIELD | Bausch & Lomb Healthcare and Optics Worldwide | 1995-07-26 |
| K915861 | MEDILENS-CS CORNEAL SHIELD | Chiron Ophthalmics | 1992-03-06 |
| K914529 | SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS | Oasis Medical, Inc. | 1991-11-13 |
| K913148 | COLLAGEN SHIELD FOR ACUTE CARE | Vitaphore Corp. | 1991-10-15 |
| K905825 | COLLAGEN SHIELD, VARIOUS MODELS | Chiron Ophthalmics | 1991-06-10 |
| K902558 | COLLAGEN SHIELD FOR ACUTE CARE | Vitaphore Corp. | 1990-08-17 |
| K901880 | MEDILENS(TM) CORNEAL SHIELD | Chiron Ophthalmics | 1990-07-02 |
| K884962 | ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA | Bausch & Lomb Pharmaceutical, Inc. | 1990-02-09 |
| K885015 | COI 72 HR COLLAGEN SHIELD | Chiron Ophthalmics | 1989-06-23 |
| K884961 | ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1989-02-13 |
| K884960 | ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1989-02-13 |
| K885016 | COI 24 HR COLLAGEN SHIELD | Chiron Ophthalmics | 1989-02-01 |
| K884364 | LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 |
| K884363 | LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 |
| K882762 | COLLAGEN SHIELD | Chiron Ophthalmics | 1988-09-12 |
Legacy Summary#
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FDA Review#
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