The following data is part of a premarket notification filed by United Products & Instruments, Inc. with the FDA for Colpo-master.
| Device ID | K073053 |
| 510k Number | K073053 |
| Device Name: | COLPO-MASTER |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | UNITED PRODUCTS & INSTRUMENTS, INC. 377 ROUTE 17 S Hasbrouck, NJ 07604 |
| Contact | George Myers |
| Correspondent | Bob Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-10-30 |
| Decision Date | 2007-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040019955 | K073053 | 000 |
| 00816668020089 | K073053 | 000 |
| 00816668020072 | K073053 | 000 |
| 00816668020065 | K073053 | 000 |
| 00816668020058 | K073053 | 000 |
| 00816668020041 | K073053 | 000 |
| 00816668020034 | K073053 | 000 |
| 00816668020027 | K073053 | 000 |
| 40612479200195 | K073053 | 000 |
| 40612479200034 | K073053 | 000 |
| 40612479200027 | K073053 | 000 |
| 40612479200010 | K073053 | 000 |
| 00304040019795 | K073053 | 000 |
| 00304040019801 | K073053 | 000 |
| 00304040019818 | K073053 | 000 |
| 00304040019948 | K073053 | 000 |
| 00304040019931 | K073053 | 000 |
| 00304040019924 | K073053 | 000 |
| 00304040019917 | K073053 | 000 |
| 00304040019900 | K073053 | 000 |
| 00304040019870 | K073053 | 000 |
| 00304040019863 | K073053 | 000 |
| 00304040019856 | K073053 | 000 |
| 00304040019849 | K073053 | 000 |
| 00304040019832 | K073053 | 000 |
| 00304040019825 | K073053 | 000 |
| 40612479200003 | K073053 | 000 |