The following data is part of a premarket notification filed by Bio Med Sciences, Inc. with the FDA for Oleeva Foam.
| Device ID | K002109 |
| 510k Number | K002109 |
| Device Name: | OLEEVA FOAM |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | BIO MED SCIENCES, INC. 1111 HAMILTON ST. Allentown, PA 18101 |
| Contact | Mark E Dillon |
| Correspondent | Mark E Dillon BIO MED SCIENCES, INC. 1111 HAMILTON ST. Allentown, PA 18101 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-12 |
| Decision Date | 2000-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810050460269 | K002109 | 000 |
| 10810050460177 | K002109 | 000 |
| 10810050460191 | K002109 | 000 |
| 10810050460207 | K002109 | 000 |
| 10810050460214 | K002109 | 000 |
| 10810050460221 | K002109 | 000 |
| 10810050460238 | K002109 | 000 |
| 10810050460245 | K002109 | 000 |
| 10810050460252 | K002109 | 000 |
| 10810050460160 | K002109 | 000 |