The following data is part of a premarket notification filed by Iop, Inc. with the FDA for Osmed Tissue Expander.
| Device ID | K010852 |
| 510k Number | K010852 |
| Device Name: | OSMED TISSUE EXPANDER |
| Classification | Expander, Tissue, Orbital |
| Applicant | IOP, INC. 3151 AIRWAY AVE., BLDG. I-1 Costa Mesa, CA 92626 |
| Contact | Jason Malecka |
| Correspondent | Jason Malecka IOP, INC. 3151 AIRWAY AVE., BLDG. I-1 Costa Mesa, CA 92626 |
| Product Code | NFM |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-21 |
| Decision Date | 2001-08-13 |