The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Grip-a-boots.
| Device ID | K955463 |
| 510k Number | K955463 |
| Device Name: | GRIP-A-BOOTS |
| Classification | Guard, Instrument |
| Applicant | SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Contact | Karen K Sylvia |
| Correspondent | Karen K Sylvia SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Product Code | LXZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-29 |
| Decision Date | 1996-01-23 |