The following data is part of a premarket notification filed by Techton, Inc. with the FDA for Techton Protective Pad.
Device ID | K873038 |
510k Number | K873038 |
Device Name: | TECHTON PROTECTIVE PAD |
Classification | Curtain, Protective, Radiographic |
Applicant | TECHTON, INC. 3116 CAMINO REAL CT. NE Albuquerque, NM 87111 |
Contact | Charles A Kelsey |
Correspondent | Charles A Kelsey TECHTON, INC. 3116 CAMINO REAL CT. NE Albuquerque, NM 87111 |
Product Code | IWQ |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-04 |
Decision Date | 1989-04-03 |