The following data is part of a premarket notification filed by Hydro-med Products, Inc. with the FDA for X-ray Drapes.
Device ID | K923099 |
510k Number | K923099 |
Device Name: | X-RAY DRAPES |
Classification | Curtain, Protective, Radiographic |
Applicant | HYDRO-MED PRODUCTS, INC. P.O. BOX 540905 Dallas, TX 75220 |
Contact | Bonnie Beasley |
Correspondent | Bonnie Beasley HYDRO-MED PRODUCTS, INC. P.O. BOX 540905 Dallas, TX 75220 |
Product Code | IWQ |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-25 |
Decision Date | 1992-10-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850301007334 | K923099 | 000 |