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 |