The following data is part of a premarket notification filed by Regu-tech Assoc., Inc. with the FDA for Tyco Baby Sesame Street Soft Teether.
Device ID | K963912 |
510k Number | K963912 |
Device Name: | TYCO BABY SESAME STREET SOFT TEETHER |
Classification | Ring, Teething, Fluid-filled |
Applicant | REGU-TECH ASSOC., INC. 200 FIFTH AVE., ROOM 350 New York, NY 10010 |
Contact | Robert J Staab |
Correspondent | Robert J Staab REGU-TECH ASSOC., INC. 200 FIFTH AVE., ROOM 350 New York, NY 10010 |
Product Code | KKO |
CFR Regulation Number | 872.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-30 |
Decision Date | 1996-11-06 |