SOFT SILICONE ELASTOMER SPONGE EXPLANT
Device Facts
| Record ID | K780987 |
|---|---|
| Device Name | SOFT SILICONE ELASTOMER SPONGE EXPLANT |
| Applicant | Medical Instrument Research Assoc., Inc. |
| Product Code | HOZ · Ophthalmic |
| Decision Date | Sep 28, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4790 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
