The following data is part of a premarket notification filed by Span-america Medical Systems, Inc. with the FDA for Pressure Guard Site Select (a).
| Device ID | K973169 |
| 510k Number | K973169 |
| Device Name: | PRESSURE GUARD SITE SELECT (A) |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | SPAN-AMERICA MEDICAL SYSTEMS, INC. 70 COMMERCE DR. P.O. BOX 5231 Greenville, SC 29615 |
| Contact | Wanda Totton |
| Correspondent | Wanda Totton SPAN-AMERICA MEDICAL SYSTEMS, INC. 70 COMMERCE DR. P.O. BOX 5231 Greenville, SC 29615 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-25 |
| Decision Date | 1998-02-20 |
| Summary: | summary |