The following data is part of a premarket notification filed by Intermed Group, Inc. with the FDA for Intermed Zoom Colposcope.
| Device ID | K031639 |
| 510k Number | K031639 |
| Device Name: | INTERMED ZOOM COLPOSCOPE |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | INTERMED GROUP, INC. 3550 23RD AVE. SOUTH, SUITE #1 Lake Worth, FL 33461 |
| Contact | George Garamy, Jr. |
| Correspondent | George Garamy, Jr. INTERMED GROUP, INC. 3550 23RD AVE. SOUTH, SUITE #1 Lake Worth, FL 33461 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-27 |
| Decision Date | 2003-08-22 |
| Summary: | summary |