The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Sterile Imaging Products.
| Device ID | K934731 |
| 510k Number | K934731 |
| Device Name: | MEDSURG STERILE IMAGING PRODUCTS |
| Classification | Protector, Skin Pressure |
| Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Contact | Thomas B Bonner, Jr. |
| Correspondent | Thomas B Bonner, Jr. MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Product Code | FMP |
| CFR Regulation Number | 880.6450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-29 |
| Decision Date | 1994-03-28 |