The following data is part of a premarket notification filed by Hydro-med Products, Inc. with the FDA for Universal Video/laser Arm Drape.
| Device ID | K934630 |
| 510k Number | K934630 |
| Device Name: | UNIVERSAL VIDEO/LASER ARM DRAPE |
| Classification | Drape, Surgical |
| Applicant | HYDRO-MED PRODUCTS, INC. 2930 LADYBIRD LN. Dallas, TX 75220 |
| Contact | Bonnie Beasley |
| Correspondent | Bonnie Beasley HYDRO-MED PRODUCTS, INC. 2930 LADYBIRD LN. Dallas, TX 75220 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-24 |
| Decision Date | 1994-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855495007386 | K934630 | 000 |
| 00850301007280 | K934630 | 000 |
| 00850301007266 | K934630 | 000 |
| 00850301007235 | K934630 | 000 |
| 00850301007211 | K934630 | 000 |
| 00850301007198 | K934630 | 000 |
| 00850301007167 | K934630 | 000 |
| 00850301007129 | K934630 | 000 |
| 00850301007082 | K934630 | 000 |
| 00850301007044 | K934630 | 000 |
| 00850301007013 | K934630 | 000 |
| 10855495007389 | K934630 | 000 |
| 00850301007303 | K934630 | 000 |
| 00850301007631 | K934630 | 000 |
| 10855495007372 | K934630 | 000 |
| 10855495007365 | K934630 | 000 |
| 10855495007358 | K934630 | 000 |
| 10855495007348 | K934630 | 000 |
| 20855495007331 | K934630 | 000 |
| 20855495007324 | K934630 | 000 |
| 10850301007683 | K934630 | 000 |
| 10850301007676 | K934630 | 000 |
| 10850301007669 | K934630 | 000 |
| 10850301007652 | K934630 | 000 |
| 10850301007645 | K934630 | 000 |
| 10855495007341 | K934630 | 000 |